Medical connector

ABSTRACT

A luer connector including a rigid housing having a first end and a second end. The housing further including a rigid tubular male portion at the first end, a rigid tubular female portion at the second end, and a longitudinal opening therethrough. The male portion is configured to be engageable with a female connector. The female portion is configured to be engageable with a male connector and to prevent the disengagement of the male connector from the female portion. In some embodiments, the female portion is configured to maintain a fixed rotational position when the male connector is being threaded therewith, but to rotate with the male connector once the male connector has become fully engaged with the female portion so as to prevent the male connector from becoming unthreaded from the female portion.

RELATED APPLICATIONS

This application is related to and claims the benefit of U.S.Provisional Patent Application Nos. 60/938,428, filed on May 16, 2007,60/978,697, filed on Oct. 9, 2007, and 61/042,016, filed Apr. 3, 2008,each of which is incorporated by reference in its entirety herein. Thisapplication also incorporates by reference in their entireties U.S.Provisional Patent Application No. 60/696,894, filed on Jul. 6, 2005,and to U.S. Provisional Patent Application No. 60/707,319, filed on Aug.11, 2005, and U.S. patent application Ser. No. 11/417,604, filed on May3, 2006 and Ser. No. 11/482,176, filed on Jul. 6, 2006.

BACKGROUND OF THE INVENTIONS

1. Field of the Inventions

These inventions relate generally to medical connectors through whichfluids flow, and in particular, to medical connectors with male luers.

2. Description of the Related Art

Systems of connectors, valves, and tubing are routinely used inhospitals and other medical settings for facilitating the transfer offluids to and from patients. It is often a challenge to keep suchsystems sterile and to prevent leakage of fluids when the variouscomponents are engaged and disengaged.

In order to maintain a barrier to bacteria, debris, and fluid leakage,female connectors often have been provided with closures, such as septa,flexible seals, or other impediments, at their mating ends. When a maleluer connector is engaged with the female connector, the closure of thefemale connector is temporarily opened, pierced, or moved to allow fluidto flow between the two connectors. Male connectors typically employneedles or luers to open, pierce, or move the closure on the femaleconnectors.

In many systems, only the female connectors are automatically blockedfrom the external environment when disengaged. Male luer connectors aregenerally not provided with automatic closing mechanisms. Male luerconnectors sometimes employ additional components, such as caps, to stopthe flow of fluid and impede the entry of bacteria and debris. Becausesuch closure mechanisms are not automatic (or not used at all), maleluer connectors are sometimes left unsealed, allowing fluid to drip out.This may increase the risk of unsanitary conditions inside and outsideof the fluid transfer system. In addition, in some medical applicationssuch as certain chemotherapy treatments, the fluids in the tubing andconnectors can be harmful if released.

Moreover, in the busy environment of hospitals and other medicalsettings, health care providers must often quickly manipulate multiplemedical implements with one hand, making it difficult to retrieve maleluer caps and rapidly attach them upon disengagement of male connectors.In addition, male luer connectors are often employed at the downstreamend of gravity-fed fluid sources such as IV bags. When the connectorsand tubing are initially connected to such sources, they are generallyempty (i.e., filled with air) and must be primed with fluid before theycan be connected to a patient. During the priming procedure, fluid isallowed to flow from the upstream end of the tubing toward the male luerconnector on the downstream end. As the fluid flows through the tubing,the air in the tubing escapes through the male connector on thedownstream end into the environment. Once the fluid itself reaches themale connector, it can also escape and spill out. Because male luerconnectors do not usually close automatically after priming, the maleluer often drips out a small amount of fluid as the male connector israpidly moved into mating engagement with a female connector. For thisreason, the male luer is generally held over a sink or trash can at theend of the priming procedure to contain the dripping fluid.

There is a need for a closeable male luer connector that automaticallyopens when engaged with a female connector and automatically closes whendisengaged from such connector to minimize or eliminate dripping duringpriming and other procedures and to improve the barrier of the fluidtransfer system against bacteria and other debris. There is also a needfor a closeable male luer connector with a female connector having alocking arrangement or other arrangement that permits the female portionof the male luer connector to be coupled with a corresponding maleconnecting portion of a male connector or other medical device such as asyringe, but inhibits the ability of, or substantially prevents, thefemale portion of the male luer connector from becoming decoupled fromthe corresponding male luer portion of the coupled component.

SUMMARY OF SOME EMBODIMENTS

Disclosed are various embodiments of medical connectors with closeablemale luers. It is contemplated that the features of the variousembodiments disclosed herein are combinable to form additionalembodiments. Such combinations are within the scope of this disclosure.

In an exemplary embodiment, a male luer connector has a main housingwith first and second ends. The second end of the housing comprises amale luer and a shroud surrounding at least a portion of the male luer.The shroud has screw threads disposed on an internal wall thereof. Atubular valve member with a fluid pathway is disposed within thehousing. The valve member has a tip on its second end. In the regionnear the tip, a pair of fluid holes is positioned on opposite sides ofthe valve member. The tip is configured to abut snugly against aninternal wall of the male luer in a region at or near the second end ofthe male luer. The valve member also has a pair of struts directedtowards the second end. The struts extend axially through a portion ofthe housing, and the ends of the struts towards the second end arepositioned within a space between the male luer and the shroud on thesecond end of the housing. A length of medical tubing is connected tothe connector. An end of the tubing is attached to the first end of thevalve member by adhesive, welding, or some other means. A resilient,elastomeric member extends from a mid-section region on the outside ofthe housing to a region at or near the first end of the valve memberwithin the housing.

In a substantially closed state, the resilient member is configured topull the housing and the tubular valve member together along theirrespective axes. In this state, the tip of the valve member is pressedinto close contact with a portion of the internal wall on the second endof the male luer, and fluid flow from the medical tubing through thetubular valve member is impeded. Fluid generally cannot escape throughthe opening on the second end of the male luer because such opening isblocked by the tip of the valve member.

When a force is applied to separate the valve member from the housing,the resilient member is stretched and the tip of the valve member isdisplaced in the direction of the first end from the second end of themale luer. This separating force can be applied manually, for example,by grasping the external wall of the housing with two fingers andgrasping the tubing adhered to the first end of the valve member withtwo other fingers, and then moving the fingers in opposite direction.The separating force can also be applied automatically by a differentmanual action. For example, the action of connecting the male luer to afemale end of another medical implement can automatically separate thevalve member from the housing. As the advancing end of the femaleconnector proceeds up the screw threads on the second end of the housingof the male luer connector, the female connector makes contact with andexerts a force directed towards the first end against the struts of thevalve member. This force moves the valve member towards the first endagainst the biasing force directed towards the second end exerted by theresilient member. In this opened state, fluid is permitted to flowthrough the opposing holes, around the tip of the valve member, and outof the connector through the gap between the tip of the valve member andthe internal wall on the second end of the male luer. In someembodiments, the valve member is automatically advanced in the directionof the first end when the valve member contacts a fluid conduit (e.g., aspike positioned within a female connector) as the male and femaleconnectors are brought together.

When the separating force is removed, for example, by releasing themanual grip on the housing and the tubing, or by detaching the femaleconnector from the second end of the housing, the resilient member onceagain draws the housing and the valve member together. This causes thetip on the second end of the valve member to abut closely against aportion of the internal wall in a region near the second end of the maleluer, and impedes fluid flow out of the valve.

One embodiment that prevents the decoupling of the female portion of themale luer connector from the corresponding male luer portion of thecoupled component is described herein. In brief, without limitation,this embodiment of a luer connector can comprise a rigid housing havinga first end and a second end. The housing can further comprise a rigidtubular male portion at the first end, a rigid tubular female portioncomprising a locking arrangement at the second end, and a longitudinalopening therethrough. The male portion is configured to be engageablewith a female connector. The female portion is configured to beengageable with a male connector. The locking arrangement is configuredto substantially allow rotation of the luer connector relative to themale connector in a first direction so as to allow the female portion tothreadably engage an internal thread of the male connector, and isconfigured to substantially prevent rotation of the luer connectorrelative to the male connector in a second direction.

Another embodiment that can prevent the decoupling of the female portionof the male luer connector from the corresponding male connectingportion of the coupled component is described herein. In brief, withoutlimitation, this embodiment of a luer connector can comprise a rigidhousing having a first end and a second end. The housing further cancomprise a rigid tubular male portion at a first end, a rigid tubularfemale portion comprising a breakaway arrangement at a second end, and alongitudinal opening therethrough. The male portion can be configured tobe engageable with a female connector. The female portion can beconfigured to be engageable with a male connector. The breakawayarrangement can substantially prevent the removal of the correspondingmale connector portion of the coupled component from the female portionof the luer connector.

In more detail, but without limitation, the breakaway arrangement can beconfigured to allow a threaded male connector portion of the coupledcomponent to rotate relative to a threaded female portion of the luerconnector in a first, tightening direction until the male connectorportion of the coupled component is substantially completely threadedlyengaged with the female portion of the luer connector. Additionally,without limitation, the breakaway arrangement can be configured toprevent the male connector portion of the coupled component fromrotating relative to the female portion of the luer connector in asecond, loosening direction after the male connector portion of thecoupled component has been substantially completely engaged with thefemale portion of the luer connector, thus preventing the coupledcomponent from easily decoupling from the luer connector.

In some embodiments, this is accomplished as follows. As will bedescribed in greater detail below, the female portion of the luerconnector can comprise an end cap between the main housing body and thefemale connector. The end cap can comprise a first end cap component anda second end cap component. The second end cap component can besupported by a housing member, and the first end cap component can besupported by the second end cap component and can be partiallypositioned on the inside of the second end cap component. The first endcap component of the luer connector can comprise one or more tabsprotruding radially outwardly from an outside surface thereof that canengage with complementary tabs protruding radially inwardly from aninside surface of the second end cap component. In a first state, theengagement of the tabs can prevent the first end cap component of theluer connector from rotating freely within the second end cap component.The tabs protruding outwardly from the first end cap component of theluer connector can be configured to shear or break off when apredetermined level of torque is applied to the first end cap componentof the luer connector, which, in some embodiments, can occur when a maleluer portion of the coupled component is substantially fully threadablyengaged with the first end cap component of the luer connector. Once thetabs on the first end cap component of the luer connector have shearedor broken off, the first end cap component of the luer connector thencan rotate substantially freely within the second end cap component sothat the male portion of the coupled component cannot be rotatedrelative to the first end cap component. In other words, when the maleportion of the coupled component is rotated relative to the luerconnector, the first end cap component can rotates in unison with themale portion of the coupled component so that the male portion of thecoupled component is substantially prevented from decoupling from thefirst end cap component, hence, the luer connector.

In some embodiments, a method of engaging a medical implement with aconnector is provided, the method comprising the steps of connecting afirst end of a medical implement with a first end of a connector Theconnector can comprise a rigid housing with a first end configured tothreadingly engage the first end of the medical implement. The first endcan comprise a first portion comprising at least one engaging surfaceand a second portion co-axially aligned with the first portion andcomprising at least one engaging surface. The first and second portionscan be configured to be in a first, locked configuration wherein therespective engaging surfaces of the first and second portions cooperateto prevent or impede the first and second portions from rotatingrelative to each other and a second, substantially unimpeded positionwherein the first and second portions are able to rotate relative toeach other. The method further comprising twisting the medical implementrelative to the connector to threadingly advance the first end of themedical implement past the first end of the connector until the medicalimplement and the connector reach a substantially fully threadinglyengaged point. Further twisting the medical implement relative to theconnector in the advancing direction beyond the substantially fullythreadingly engaged point disengages the cooperating engaging surfacesof the first and second portions to permit the first portion to rotaterelative to the second portion without disengaging the medical implementfrom the connector.

Also disclosed herein are other features and configurations for theforegoing embodiments, as well as additional embodiments for otherconnectors with closeable male luers. Such embodiments generally includemeans for permitting or impeding fluid flow through a male luer on aconnector, preferably automatically upon connection with a correspondingfemale connector. Such embodiments can also include features andconfigurations that permit the female portion of the male luer connectorto be coupled with a corresponding male connector portion of anotherconnector or medical device such as a syringe, while inhibiting orsubstantially preventing the decoupling of the female portion of themale luer connector from the corresponding male connector portion of thecoupled component.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain embodiments of this inventions will now be discussed in detailwith reference to the following figures. These figures are provided forillustrative purposes only, and the inventions are not limited to thesubject matter illustrated in the figures.

FIG. 1A shows a perspective view of an embodiment of a male luerconnector attached to tubing configured to receive fluid from a hanginggravity-fed IV bag. In this and other figures, the relative size of theconnector and attached tubing is increased in comparison to otherobjects to facilitate viewing certain details.

FIG. 1B shows a perspective view of the connector of FIG. 1A in astretched, substantially opened configuration.

FIG. 1C shows a perspective view of an embodiment of the connector ofFIG. 1A being connected to an exemplary female connector attached totubing inserted into a patient.

FIG. 2 shows a perspective view of an embodiment of a closeable maleluer connector.

FIG. 3 shows a perspective view of a housing portion of the connector ofFIG. 2.

FIG. 4A shows a perspective view of a valve member portion of theconnector of FIG. 2.

FIG. 4B shows a perspective view of another embodiment of a valve memberportion of the connector of FIG. 2.

FIG. 4C shows a cross-sectional view of the embodiment of the valvemember portion of the connector of FIG. 4B.

FIG. 5 shows a perspective view of a resilient member of the connectorof FIG. 2.

FIG. 6 shows a perspective view of a sealing portion of the connector ofFIG. 2. The relative size of the sealing portion is increased incomparison with the components of the connector shown in other figuresto facilitate viewing.

FIG. 7 shows a perspective view of certain components of the connectorof FIG. 2 in a partially assembled configuration. The housing portion ofFIG. 5 is not shown in FIG. 7.

FIG. 8 shows a cross-sectional view of the connector of FIG. 2 adjacenta female portion of another medical implement. At this stage, fluid isimpeded through the connector of FIG. 2.

FIG. 9 shows a cross-sectional view of the connector of FIG. 2 inengagement with the medical implement of FIG. 8. Fluid is flowingthrough the engaged connectors.

FIG. 10 shows a cross-sectional view of the connector of FIG. 2 adjacentanother medical implement with a closeable female luer connector. Atthis stage, fluid is impeded through the connector of FIG. 2 and thefemale luer connector.

FIG. 11 shows a cross-sectional view of the connectors of FIG. 10 afterengagement. Fluid is flowing through the engaged connectors.

FIG. 12 shows a perspective of the connector of FIG. 2 adjacent asyringe with a male luer tip. At this stage, fluid is impeded throughthe connector.

FIG. 13 shows a perspective view of the components of FIG. 12 afterengagement. At this stage, fluid is still impeded through the connector.

FIG. 14 shows a cross-sectional view of the connector and the male luertip of the syringe of FIG. 13.

FIG. 15 shows a perspective view of the a closeable male luer connectorlocated with its first end adjacent a syringe with a male luer tip andwith its second end located adjacent a hypodermic needle with a femaleluer attachment portion.

FIG. 16 shows a perspective view of the components of FIG. 15 inengagement. At this stage, fluid can flow through the connector.

FIG. 17 is a cross-sectional view of the connector, male luer tip of thesyringe, and hypodermic needle of FIG. 16. At this stage, fluid can flowthrough the connector.

FIG. 18A is a perspective view of another embodiment of a closeable maleluer connector.

FIG. 18B is a cross-sectional view of the connector of FIG. 18A.

FIG. 18C is a detail of the cross-sectional view of the connector ofFIG. 18A.

FIG. 19 is a perspective view of the connector of FIG. 18A locatedadjacent a syringe with a male luer tip.

FIG. 20 is a perspective view of the components of FIG. 19 inengagement.

FIG. 21 is a perspective view of another embodiment of a closeable maleluer connector engaged with a syringe with a male luer tip.

FIG. 22A is a cross-sectional view of another embodiment of a closeablemale luer connector.

FIG. 22B is a detail of the cross-sectional view of the connector ofFIG. 22A.

FIG. 23A is a side view of another embodiment of a closeable male luerconnector with a shroud.

FIG. 23B is a cross-sectional view of the connector of FIG. 23A.

FIG. 23C is a perspective view an embodiment of a closeable male luerconnector adjacent a closeable female connector. At this stage, fluidflow is impeded through the female luer connector.

FIG. 23D is a perspective view of the components of FIG. 23C inengagement.

FIG. 24A is a perspective view of another embodiment of a closeable maleluer connector.

FIG. 24B is a cross-sectional view of the connector of FIG. 24A.

FIG. 25A is a side view of another embodiment of a closeable male luerconnector with a shroud.

FIG. 25B is a cross-sectional view of the connector of FIG. 25A.

FIG. 26A is a perspective view of another embodiment of a closeable maleluer with a flexibly connected female luer connector.

FIG. 26B is a perspective view of another embodiment of a closeable maleluer with a flexibly connected female luer connector.

FIG. 27 is a perspective view of another embodiment of a closeable maleluer connector.

FIG. 28 is a cross-sectional view of the connector of FIG. 27.

FIG. 29 is another cross-sectional view of the connector of FIG. 27.

FIG. 30 is a cross-sectional view of the connector of FIG. 27 engagedwith a syringe with a male luer tip. At this stage, fluid flow isimpeded through the male luer connector.

FIG. 31 is a cross-sectional view of the connector and syringe of FIG.30 engaged with a tube having a female luer attachment portion. At thisstage, fluid flow is permitted through this assembly.

FIG. 32 is another cross-sectional view of the connector, syringe, andtube of FIG. 31. At this stage, the connector is in the process ofclosing.

FIG. 33 is a perspective view of the connector of FIG. 27 prior toengagement with an embodiment of a priming cap.

FIG. 34 is a perspective view of another embodiment of a closeable maleluer connector.

FIG. 35 is a cross-sectional view of the connector of FIG. 34.

FIG. 36 is a perspective view of another embodiment of a closeable maleluer connector.

FIG. 37 is a cross-sectional view of the connector of FIG. 36.

FIG. 38 is a cross-sectional view of another embodiment of a closeablemale luer connector.

FIG. 39 is a cross-sectional view of the connector of FIG. 38 engagedwith a syringe with a male luer tip. At this stage, fluid flow isimpeded through the male luer connector.

FIG. 39A is a cross-sectional view of the connector and syringe of FIG.39 engaged with a tube having a female luer attachment portion. At thisstage, fluid flow is permitted through this assembly.

FIG. 40 is a cross-sectional view of another embodiment of a closeablemale luer connector.

FIG. 41 is a cross-sectional view of another embodiment of a closeablemale luer connector.

FIG. 42 is a perspective view of an embodiment of a closeable male luerconnector in a closed position.

FIG. 43 is a perspective view of the closeable male luer connector ofFIG. 42 in an open position.

FIG. 44 is a cross-sectional view of the closeable male luer connectorof FIG. 42.

FIG. 45 is a cross-sectional view of the closeable male luer connectorof FIG. 43 taken along plane orthogonal to the cross-sectional plane ofFIG. 41.

FIG. 46 is a cutaway perspective view of the closeable male luerconnector of FIG. 42 taken along the line 46-46.

FIG. 47 is a perspective view of the valve member component of thecloseable male luer connector of FIG. 42.

FIG. 48 is a perspective view of the female connector component of thecloseable male luer connector of FIG. 42.

FIG. 49 is an exploded view of the components of an embodiment of acloseable male luer connector.

FIG. 50 is an exploded view of the components of an embodiment of acloseable male luer connector.

FIG. 51 is a perspective view of an engagement arrangement of anembodiment of a component of a non-reversible closeable male luerconnector.

FIG. 52 is a cross-sectional view of the embodiment of FIG. 51 takenalong the line 52-52.

FIG. 53 is a side view of an embodiment of a component of anon-reversible closeable male luer connector.

FIG. 54 is a side view of the component of FIG. 53.

FIG. 55 is a side view of an embodiment of a component of anon-reversible closeable male luer.

FIG. 56 is a side view of the component of FIG. 55.

FIG. 57 is a perspective view of an embodiment of a closeable male luerconnector in a closed position.

FIG. 58 is a cross-sectional view of the closeable male luer connectorof FIG. 57 taken along the line 58-58.

FIG. 59 is a perspective view of the female connector component of thecloseable male luer connector of FIG. 57.

FIG. 60 is a side view of the female connector component shown in FIG.59.

FIG. 61 is a front view of the female connector component shown in FIG.59.

FIG. 62 is an enlarged side view of an end cap portion of the femaleconnector component shown in FIG. 59 threadably inserted into a maleconnecting portion of a mating component.

FIG. 63 is a perspective view of another embodiment of a closeable maleluer connector in a closed position.

FIG. 64 is a side view of the embodiment of the closeable male luerconnector shown in FIG. 63 again in a closed position, showing certaininternal features of the closable male luer connector in dashed lines.

FIG. 65 is an exploded perspective view of the components of theembodiment of the closeable male luer connector shown in FIG. 63.

FIG. 66 is an end view of the female end of the embodiment of theclosable male luer connector shown in FIG. 63.

FIG. 67 is a cross-sectional view of the embodiment of the closeablemale luer connector shown in FIG. 63, taken along the line 67-67 in FIG.66.

FIG. 68 is an enlarged cross-sectional view of the embodiment of theclosable male luer connector shown in FIG. 63, taken along curve 68-68in FIG. 67.

FIG. 69 is a cross-sectional view of the embodiment of the closeablemale luer connector shown in FIG. 63, taken along the line 69-69 in FIG.66.

FIG. 70 is an enlarged cross-sectional view of the embodiment of theclosable male luer connector shown in FIG. 63, taken along curve 70-70in FIG. 69.

FIG. 71 is a perspective view of a portion of the embodiment of thecloseable male luer connector shown in FIG. 63.

FIG. 72 is a perspective view of a portion of the embodiment of thecloseable male luer connector shown in FIG. 63.

FIG. 73 is a perspective view of a portion of the closeable male luerconnector shown in FIG. 63.

FIG. 74 is a side view of the component shown in FIG. 73.

FIG. 75 is a perspective view of a portion of the embodiment of thecloseable male luer connector shown in FIG. 63.

FIG. 76 is an end view of the component shown in FIG. 75.

FIG. 77 is a cross-sectional view of the component shown in FIG. 75,taken along the line 77-77 in FIG. 76.

FIG. 78A is a side view of an exemplifying coupled component threadedlyengaged with the embodiment of the closeable male luer connector shownin FIG. 63.

FIG. 78B is a side view of an exemplifying coupled componentsubstantially fully threadedly engaged with the embodiment of thecloseable male luer connector shown in FIG. 63.

FIG. 78C is a side view of an exemplifying coupled componentsubstantially fully threadedly engaged with another embodiment of acloseable male luer connector.

FIG. 79A is a cross-sectional view of another embodiment of a luerconnector in a closed position.

FIG. 79B is a cross-sectional view of the embodiment of the luerconnector shown in FIG. 79A in an open position.

FIG. 80A is a cross-sectional view of another embodiment of a luerconnector in a closed position.

FIG. 80B is a cross-sectional view of the embodiment of the luerconnector shown in FIG. 80A in an open position.

FIG. 81A is a cross-sectional view of another embodiment of a luerconnector in a closed position.

FIG. 81B is a cross-sectional view of the embodiment of the luerconnector shown in FIG. 81A in an open position.

FIG. 82A is a cross-sectional view of another embodiment of a luerconnector in a closed position.

FIG. 82B is a cross-sectional view of the embodiment of the luerconnector shown in FIG. 82A in an open position.

FIG. 83A is a cross-sectional view of another embodiment of a luerconnector in a closed position.

FIG. 83B is a cross-sectional view of the embodiment of the luerconnector shown in FIG. 83A in an open position.

FIG. 84A is a cross-sectional view of another embodiment of a luerconnector in a closed position.

FIG. 84B is a cross-sectional view of the embodiment of the luerconnector shown in FIG. 84A in an open position.

FIG. 85A is a cross-sectional view of another embodiment of a luerconnector in a closed position.

FIG. 85B is a cross-sectional view of the embodiment of the luerconnector shown in FIG. 85A in an open position.

FIG. 86A is a cross-sectional view of another embodiment of a luerconnector in a closed position.

FIG. 86B is a cross-sectional view of the embodiment of the luerconnector shown in FIG. 86A in an open position.

DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS

The following detailed description is now directed to certain specificembodiments of the disclosure.

In some aspects of the embodiments described herein, a variety of meansare shown for closing the second end of a male luer connector. In someembodiments, these closing mechanisms function to prevent and/or impedefluid from escaping from or entering into the male luer, while allowingfluid flow when the male luer is manually opened or engaged with acorresponding female luer. As used herein, terms such as “closed” or“sealed” should be understood as obstructions or barriers to fluid flow.These terms should not be understood to require that a particularstructure or configuration achieves a complete fluid closure in allcircumstances.

In FIG. 1A, an embodiment of a closeable male luer connector 10 is shownin a closed position. The luer connector 10 is attached to a gravity-fedIV bag 9 filled with fluid hanging from a pole stand 11. At the bottomof the bag 9, a section of tubing 13 is attached. The opposite end ofthe tubing 13 is connected to the first end 12 of the luer connector 10.A closing mechanism on the interior of the second end 14 of the luerconnector 10 prevents the fluid contained within the bag 9 from flowingthrough the tubing 13 and leaking out of the luer connector 10, as longas the luer connector 10 remains in a closed configuration.

In FIG. 1B, the connector 10 is illustrated in an open position. Fluidcan flow out into the first end 12 of the connector 10 and out of thesecond end 14 of the connector 10. A health care provider can move themale luer connector 10 into this configuration by grasping the secondend of the closeable male luer 10 with two fingers, grasping the tubing13 with two other fingers, and gently moving the fingers in oppositedirections.

The IV delivery system illustrated in FIGS. 1A and 1B can be easilyreadied for fluid communication with a patient. In most circumstances,the tubing 13 is filled with air when it is initially connected to theIV bag 9. If the other end of the tubing 13 is connected to a closedconnector, as illustrated in FIG. 1A, the air cannot escape and fluidcannot enter the tubing 13 from the IV bag 9. The luer connector 10 istherefore manually moved into the opened position until all of the airhas been purged through the luer 10 and the fluid in the IV bag 9 fillsthe tubing 13 and connector 10. This procedure is known as “priming.” Assoon as the fluid line and connector are properly primed, the healthcare provider can quickly release the opposing forces applied to thesecond end 14 of the luer connector 10 and the tubing 13, and theclosing mechanism of the luer connector 10 can rapidly stop the flow offluid through the luer connector 10.

Referring now to FIG. 1C, a catheter 17 has been inserted into apatient's arm 15. The catheter 17 penetrates the skin of the arm 15 andis preferably fluidly connected with the patient's bloodstream. Thecatheter 17 is also connected to a length of medical tubing 19 attachedto a female medical connector 21. The example of a female medicalconnector 21 illustrated in FIG. 1C is a version of the Clave® connectormanufactured by ICU Medical, Inc., San Clemente, Calif. Variousembodiments of a connector of this type are illustrated and described inU.S. Pat. No. 5,685,866, which is incorporated herein by reference inits entirety. It is contemplated that many of the male luer embodimentsdisclosed herein can be used with other types of female connectors. Thetubing 19, catheter 17, and female connector 21 were previously primedwith fluid using standard procedures. The luer connector 10 is primed asdescribed previously and brought into engagement with the femaleconnector 21. As described in further detail below, when the maleconnector 10 and female connector 21 are engaged, fluid is permitted toflow from the IV bag 9 into the patient. When the male connector 10 andfemale connector 21 are disengaged, fluid is once again prevented fromflowing out of the second end 14 of the male connector 10. In general,fluid is also prevented from flowing out of the opening in the femaleconnector 21.

The embodiment illustrated in FIGS. 1A-1C is described in further detailbelow. Each of the other embodiments disclosed herein can be used in theillustrated fluid system, and in various modifications and alternativesthereof. Further, it is contemplated that the various embodiments ofconnectors in accordance with the inventions can be used in a widevariety of additional medical fluid systems. For example, the disclosedconnectors can also be used to transfer bodily fluids such as blood,urine, or insulin, nourishing fluids, and/or therapeutic fluids such asfluids used in chemotherapy treatments. The disclosed connectors canalso be used to interconnect various other components of fluid transfersystems.

Referring now to FIGS. 2-9, the closeable male luer of FIGS. 1A-1C isillustrated in greater detail. As illustrated in FIG. 2, the assembledluer connector 10 comprises four portions: a housing 23, a valve member16, a resilient member 18, and a sealing ring 20 (not visible in FIG.2). These portions are individually illustrated in FIGS. 3 through 6,and will be discussed in further detail with reference to these Figures.The luer connector 10 can be constructed of more or fewer portions, andsuch portions can be combined into different configurations.

FIG. 3 illustrates the housing 23 of the connector 10, apart from theother portions of the luer connector 10. The housing 23 is generally atube-like structure with an axial passageway 28 that extends from thefirst end 12 of the connector 10 through the upper housing 34, and themiddle portion 32, and the luer tip 22, to the second end 14 of thehousing 23. In some embodiments, the length of the housing 23 from thefirst end 12 to the luer tip 22 is approximately 1 ⅛ inches. The housing23 is preferably, but not necessarily, less than or equal to about 1½inches from the first end 12 to the second end 14 so that the weight andbulk of the connector are minimized. The housing 23 can have anysuitable length for a particular application. The luer tip 22 connectsto the remainder of the housing 23 at a base 25 that is surrounded by ashroud 24. The end 27 of the luer tip 22 towards the second end of theluer connector 10 extends some distance beyond the edge 29 of theshroud.

The shroud 24 preferably has inner threads 26 on an interior wall thathelp securely attached the connector 10 in a removable fashion toanother medical implement. In other embodiments, the shroud 24 caninclude other structures or materials for providing a releasableconnection, including quick-release mechanisms and other means. Theshroud 24 includes a plurality of depressions 31 on an outer surface toassist the user in firmly grasping and twisting the shroud 24 of thehousing 23 with the fingers. The depressions 31 have upwardly taperingsidewalls 33 that prevent the fingers from sliding off the connector 10.On an end towards the first end of the connector 10 of each depression31, the surface of the housing 23 is approximately co-planar with thesurface of the depression 31, while on an end towards the second end 14of the connector 10 of each depression 31, the surface of the housing 23is offset from, and preferably lies above, the surface of the depression31. This configuration allows the fingers to comfortably slide in adirection towards the second end 14 of the connector 10 along thehousing 23 into a position for gripping or twisting the connector 10.Once the fingers are in the desired position, a tapered wall 33 on anend towards the second end 14 of the connector 10 of the depression 31resists further movement by the fingers in the direction of the secondend 14. A series of depressions 31 extend around substantially theentire outer surface of the shroud so that the user's fingers, whenpositioned on opposite sides of the connector 10, will likely encountera depression 31 regardless of the orientation of the connector 10 duringuse.

In the illustrated embodiment, the tip 22 has a tapered external wall.The diameter of the tip 22 becomes gradually smaller from the base 25towards the second end 27. The tip 22 includes a hole at its second end27. At the base 25 of the luer tip 22, an interior hole 35 (see FIG. 8)leads into a region of the fluid passageway 28 in the middle portion 32of the luer connector 10. The dimensions of the luer tip can be made tocomply with applicable standards and/or regulations, such as the ANSIstandards.

The interior wall of the luer tip 22 preferably includes a shelf 30 thatextends radially inwardly toward the axis of the fluid passageway 28surrounded by the luer tip 22, making the fluid passageway 28 narrowerat its second end 27 than in the region adjacent to the second end 27.In the illustrated embodiment, the surface of the shelf 29 that facesradially inwardly toward the central axis of the connector 10 is taperedin a manner similar to the taper of the outer surface of the tip 22 (seeFIGS. 8 and 9). In this configuration, the inner diameter of the shelf29 narrows in a direction from the side towards the first end to theside of the shelf 29 towards the second end. As described in furtherdetail below, the shelf 29 in the luer tip 22 helps to block and/orimpede fluid flow through the connector 10 when the second end of thevalve member 16 abuts against it.

The middle portion 32 of the housing 23 lies between the shroud 24 andthe upper housing 34. As illustrated, the middle portion 32 has asmaller outer diameter than either the shroud 24 or upper housing 34.The middle portion 32 also has two generally rectangular openings 36disposed on opposite sides of the housing 23 from each other. When theconnector 10 is assembled, the middle portion 32 is generally covered bya portion of the resilient member 18 (see, e.g., FIG. 2). As a result,the middle portion 32 does not generally come into contact with thefingers during use. Thus, in some embodiments, a grippable surface neednot be used for the middle portion 32. The middle portion 32 cantherefore have a smaller diameter and smoother surface than either ofthe other sections of the housing 23.

The upper housing 34 is generally split into two wall sections 45 a, 45b by two gaps 38 (only one shown in FIG. 3). The upper housing 34includes a series of depressions 37 similar in shape and function to thedepressions 31 on the shroud 24. The upper housing 34 may also compriseone or more protrusions 43 that extend into the gaps 38. In theassembled configuration, the protrusions 43 help to retain a portion ofthe resilient member 18 between the gaps 38 in the wall sections 45 a,45 b (see FIG. 2). In some embodiments, the protrusions 43 are taperedfrom a smaller thickness on their ends towards the first end of theconnector to a larger thickness on their ends towards the second end ofthe connector. The tapering of the protrusions 43 helps in the insertionand retention of the portion of the resilient member 18 in a desiredposition and orientation, while allowing for bending and contortion ofthe resilient member 18 during use. The protrusions 43 also help preventthe valve member 16 from advancing too far in the direction of the firstend as the connector 12 is moved into the opened position by contactingthe set of protrusions 44 toward the second end of the valve member 16.The tapering of the protrusions 43 allows the protrusions 44 of thevalve member 16 to be advanced towards the second end during assemblyinto the housing 23 past the protrusions 43 of the housing 23. Thecorners 47 towards the first end of the connector on each of the wallsections are preferably rounded to prevent snagging, scratching, orother damage or irritation to the fingers or resilient member 18 duringuse.

As shown in FIG. 3, the exterior surface of the upper housing 34includes a lower shelf 39 and the exterior surface of the shroud 24includes a shelf 41 configured to help retain a central portion of theresilient member 18 around the housing 23 in the assembled configuration(see FIG. 2). The shelf 39 of the upper housing 34 is preferablysubstantially horizontal to discourage any sliding of the resilientmember 18 in the direction of the first end of the connector. The shelf41 of the shroud 41 is preferably tapered (see FIG. 8) to assist in theproper positioning of the resilient member 18 on the housing 23 duringmanufacturing of the connector 10.

The housing 23 can be constructed from any of a number of differentmaterials. In some embodiments, the housing 23 can be constructed from arelatively rigid material, such as polycarbonate or other polymericmaterial. The housing 23 and/or valve member 16 of this embodiment, orcomponents of other embodiments, can also be constructed of ahydrophobic material, such as Bayer Makrolon, or any other suitablematerial.

Referring now to FIG. 4A, the valve member 16 of the male luer 10 isillustrated apart from the other components of the connector 10. In someembodiments, the valve member 16 comprises a fluid passageway 52 ofvarying diameter extending from the first end 48 of the valve member 16to the second end 56 thereof, surrounded by additional structures. Nearthe first end 48, the valve member 16 and corresponding section of thefluid passageway 52 are relatively wide to accommodate a section ofstandard-diameter medical tubing inserted therein. Near the middle ofthe valve member 16, a tube 40 surrounding a portion of the fluidpassageway 52 is attached to the portion near the first end of the valvemember 16. The tube is adjacent to two approximately parallel struts 42along at least a portion of the tube 40. The tube 40 can have a circularcross-section or other appropriate cross-section. The struts 42 arepreferably relatively thin and approximately planar. A first end of eachstrut 42 connects to the valve member 16 at approximately the middlesection of the valve member 16, and a second end of each strut extendstoward the second end 56 of the valve member 16. The second end 56 ofthe valve member 16 preferably extends further than the ends of thestruts. There is preferably an open space between the inner wall of eachstrut 42 and the outer wall of the tube 40.

From near the middle of the valve member 16 to the first end 48 thereof,the fluid passageway 52 comprises a wider region with protrusions 44along its external surface. Protrusions 44 form two channels 46 (onlyone is shown in FIG. 4A) lengthwise along opposing sides of the body ofthe valve member 16. In some embodiments, the struts 42 are spacedcircumferentially from the channels 46, as illustrated.

Near the first end of the valve member 16 and tube 40, a circumferentialchannel 48 may be formed around the perimeter of the body of the valvemember 16. Raised tabs 49 can be formed along the edge of the channel 48toward the first end of the connector, while the raised middle portionof the valve member 16 can form the edge of the channel 48 toward thesecond end of the connector. In some embodiments, the raised tabs 49 donot extend evenly about the perimeter of the first end of the valvemember 16, but instead have two larger sections that are spaceddiametrically from each other.

The amount of material necessary to construct the valve member 16 can bereduced by indentations made in the outer layers of this portion. Thetube 40 can have a passage 50 disposed therethrough. This passage 50preferably extends from a hole 52 at the first end of the valve member16 to a pair of holes 50 (only one shown in FIG. 4A) positionedsubstantially adjacent to the second end of the valve member 16. In theillustrated embodiment, these holes 52 are generally rectangular inshape. The region of the tube 40 near the second end of the connectorcan also be formed with only one hole or more than two holes, and othershapes for one or more of the holes can also be employed. For example,the holes 52 can be formed with a tear-drop shape (e.g., narrow on oneend and wider on an opposite end), which facilitates an injectionmolding process of manufacture. Further, in some embodiments, the valvemember 16 can be constructed without a fluid path and function as ablocking plunger for fluid flowing around the valve member 16 ratherthan a means for conveying fluid between the first and second ends ofthe connector 10.

The tube 40 of the valve member 16 comprises, at its second end, aflange section 58. The flange section 58 preferably extends further inthe radial direction than the adjacent portion of the tube 40. In someembodiments, the flange section 58 can be formed of the same orsubstantially the same material as the rest of the tube 40. The flangesection 58 preferably tapers from the first end of the valve member 16towards the second end of the tube 40. In some embodiments, the taper isformed at a 5-degree angle, and has a substantially identical taper tothat of the radially inwardly facing surface of the shelf 30 of thehousing 23. Other amounts of taper, or no taper, can also be used.

The valve member 16, like the housing 23 of FIG. 3, may be constructedfrom a number of different materials. Examples of such materials includepolycarbonate or other polymeric materials. The valve member 16 can beapproximately the same length or somewhat shorter than the housing 23.For example, the length of the valve member 16 can be approximately 1inch. In some embodiments, the valve member 16 can be substantiallyshorter than the length of the housing 23. The valve member 16 can beformed from the same rigid materials as the housing 23. In certainapplications, for example, semi-rigid or even more flexible materialsmay be desirable for use in the valve member 16, and more particularlyfor the flange section 58 toward the second end of the tube 40.

The valve member 16 can be manufactured through injection molding. Insome embodiments, at least two gates are used to facilitate distributionof molten plastic throughout the mold. Preferably, one gate can belocated along one of the sides of the valve member 16 between the end ofthe struts 42 towards the first end of the connector and the raised tabs49 and another can preferably be located near the holes 52 in the valvemember 16. The locations of the gates are not fixed, however, and otherlocations on the valve member 16 can be used for gates when injectionmolding the valve member 16. Constructing both the housing 23 and thevalve member 16 of this or other embodiments out of the same materiallessens the chance of deteriorated performance of the connector 10 dueto thermal expansion/contraction or chemical interaction between theconnector 10 and its environment.

Although the valve member 16 of the illustrated embodiment is configuredas shown in FIG. 4A, many other configurations are possible. In someembodiments, the valve member 16 can be relatively smooth on itsexternal surface, and can principally comprise the tube 40 defining thepassage 50. In still other embodiments, different numbers of struts 42can be disposed along the sides of the valve member 16.

As can be seen in the embodiment illustrated in FIG. 4B, the raised tabs150 near the first end of the valve member 16 can also comprise anexternal engaging surface 150, such as a screw thread, for removablyattaching a medical implement (not shown), such as a syringe, with thefirst end of the valve member 16.

In the embodiment illustrated in FIG. 4C, the channel 48 additionallycan be tapered along the internal surface. The taper of the channel 48can result in a decrease in width of the channel with a larger size atthe first end 180 of the valve member 16 and a smaller size towards thesecond end 184 of the valve member. The internal taper of the channel 48can compliment and closely fit with the taper of a male luer. Such aninternal taper can conform to ANSI standards and/or regulations, such asthe standard for medical syringes. In the illustrated embodiment, thetube 40 of the valve member 16 does not have a flange section 58 thatextends radially outwardly beyond the wall of the tube 40, as in theembodiment of FIG. 4A. Instead, the wall of the tube 40 tapers radiallyinwardly in the region of the second end. The second end 27 a of theluer tip 22 a can have a smaller cross-sectional second portion 170which decreases the likelihood of fluid escaping along the internalsurface of the second end 27 a of the luer tip 22 a. Near the second end27 a of the luer tip 22 a, a larger cross-sectional region 160 cantransition to the smaller cross-sectional portion 170 towards the secondend of the connector in many different ways, such as with an abruptstair-step transition as illustrated in FIG. 4C or with a gradualtapering transition, or other transitions. Some sample cross-sectionaldiameters of the opening at the second end 27 a of the luer 22 a includethose of about 2 mm or less, including about 0.5 mm, 0.75 mm, 1.0 mm,1.25 mm, 1.5 mm, and 1.75 mm. The diameters of the opening in the secondend 27 a can also be in the ranges of 0.4 mm-1.8 mm, 0.5 mm-1.5 mm, and0.5-1.0 mm. Other diameters, either inside or outside the listed rangescan also be used. Additionally, the second end of the valve member 16can be sized appropriately to occupy the space in the opening of thesecond end 27 a of the luer 22 a.

As shown in FIGS. 4B and 4C, the closeable male luer connector 10 hasboth a female end 180 and a male luer end 184. The closeable femaleconnector 21 of FIG. 1C (referenced above) and 210 of FIGS. 10 and 11(described in more detail below), as well as other standard femaleconnectors with similar external structure, also have both female andmale ends. In many embodiments, such female connectors utilize seals orother fluid barriers to impede the flow of fluid on the female end butnot on the male end. In many of the embodiments of the closeable maleluer connectors illustrated herein, there is no seal or other fluidbarrier shown on the female end. However, the female end of any of thecloseable male luer connectors disclosed herein can be configured toinclude a closeable female end. For example, the structure for selectivefluid-impedance with the female connector 21 or 210, or any of the otherstandard female connectors, could be included within the female end ofany of the closeable male luer connectors disclosed herein to provide aconnector that selectively seals or impedes fluid flow on both ends. Insome embodiments of this type with closeable female and male ends, itcan be advantageous for a resilient seal element to be positioned at ornear the female opening, as shown in U.S. Pat. No. 5,685,866. Bypositioning the seal element in this manner, it is possible to cleansethe female opening prior to use with antiseptic with a wiping motion toavoid a harmful accumulation of debris, bacteria, antiseptic, or otherunwanted substances on the seal element and/or in the region between theseal element and the housing of the connector adjacent to the sealelement.

Turning now to FIG. 5, the resilient member 18 is discussed in greaterdetail. In the illustrated embodiment, the resilient member 18 is formedfrom two rings 60, 62 separated by two elastic members 64. The rings 60,62 and/or the elastic members 64 can be made of a deformable materialconfigured to exert a restoring force when stretched. Thus, if the rings60, 62 are pulled in opposing directions, the elastic members 64function to restore the rings 60, 62 to their unextended configuration.

The elastic members 64 can be constructed from a number of elasticmaterials. In some embodiments, the elastic members 64 are made from asilicon rubber elastic material. In other embodiments, the elasticmembers 64 can be made from a shape-memory material. Instill otherembodiments, the elastic members 64 and/or the resilient member 18 cancomprise springs or other structures capable of exerting a restoringforce.

The rings 60, 62 can also be constructed from a number of materials. Insome embodiments, the rings 60, 62 are constructed from the samedeformable elastic material that comprises the elastic members 64. Thus,the rings 60, 62 can be stretched into a diameter to extend around theappropriate portion of the housing 23 to which each respective ring 60,62 is attached. The resilience of the rings 60, 62 can function toeffectively hold each ring 60, 62 in place on the housing 23. In otherembodiments, the rings 60, 62 can be constructed from rigid orsemi-rigid materials, and can, for example, comprise half-circles thatcan be snapped into and out of position. In some embodiments, theresilient member 18 can be integrated into the valve member 16 orhousing 23. In some embodiments, other structures and/or configurationscan be used to selectively urge the valve member 16 and the housing 23together in a different manner than a resilient member 18.

Turning now to FIG. 6, the sealing portion 20 is described in greaterdetail. In some embodiments, the sealing portion 20 is substantiallycylindrical and has a bore 66 extending therethrough. In someembodiments, the sealing portion 20 further comprises a pair ofgenerally rectangular protrusions 68 extending from the sidewalls of thecylindrical portion at diametrically opposed positions. The protrusions68 can have different shapes and/or positions. The sealing portion 20can also have a generally smaller-diameter middle portion 67 surroundedby two rings 69 at either end with larger diameters.

The sealing portion 20 can be constructed from a number of differentmaterials. In some embodiments, the sealing portion 20 is made from asilicon-based deformable material 70. Silicon-based deformable materialsare among those that form fluid-tight closures with plastics and otherrigid polymeric materials. The sealing portion 20 can be made from thesame material as the resilient member 18.

In FIG. 7, certain components of the male luer 10 of an embodiment areshown. As illustrated, the housing 23 is omitted. The valve member 16,the resilient member 18, and the sealing portion 20 are shown in theirrespective assembled locations. Certain interconnections between thevarious portions of the male luer 10 will now be discussed in furtherdetail. As shown, the smaller ring 62 of the resilient member 18 fitswithin the circumferential channel 54 of the valve member 16. In someembodiments, the smaller ring 62 can be stretched until it has a largerinner diameter than the raised tabs 49 at the first end of the valvemember 16. Once the small ring 62 has been advanced into position aboutthe circular channel 54, it can be released, so that it wraps tightlyabout the circular channel 54, as shown.

The larger ring 60 of the resilient member 18 extends around the middleportion 32 of the housing 23 (as shown in FIG. 2), and can be stretchedand positioned in a manner similar to that described above with respectto the small ring 62. The elastic members 64 of the resilient member 18can then extend between the small ring 62 and the larger ring 60 of theresilient member 18 and preferably extend along and within the channels46 in the valve member 16. Once located within these channels, theelastic members 64 are, in effect, trapped by the protrusions 44 alongthe channel outer walls. As seen in FIG. 2, the elastic members 64 canalso extend along the gaps 38 in the upper housing 34 of the housing 23.The gaps 38 are generally located above the channels 46 in theillustrated embodiment. The resilient member 18 thereby provides anelastic connection between the housing 23 and valve member 16, pullingthe valve member 16 into engagement with the housing 23.

The sealing portion 20, which is partially hidden by the resilientmember 18 in FIG. 7, preferably fits snugly around the tube 40 and liesin between the struts 42 of the valve member 16.

FIG. 8 illustrates a cross-section of the male luer of the presentembodiment adjacent an exemplary female connector 92. In thiscross-sectional view, the interconnections and interactions between thehousing 23, valve member 16 and sealing portion 20 can be seen ingreater detail. The valve member 16 is configured to be positionedwithin the housing 23. As illustrated, the tube 40 of the valve member16 can be inserted into and through the lumen 28. Meanwhile, the struts42 are configured to pass through corresponding slots that extendlengthwise through the middle portion 32 of the housing 23. In anassembled configuration, the struts 42 are adjacent to the tip 22 alongtwo sides, and the tube 40 is at least partially contained within thetip 22. The protrusions 44 are captured within the gaps 38 formed in theupper housing 34 of the housing 23.

A closing mechanism 56 is adapted to close the fluid passage extendingthrough the closeable male luer 10 from fluid communication with theexternal environment, preferably whenever the male luer 10 is notengaged with the female connector 92. In the illustrated embodiment, thefluid passageway 52 comprises the lumen 28 as well as the passage 54 ofthe valve member 16. The closing mechanism 56 of the illustratedembodiment comprises both the flange section 58 of the tube 40 and theinternal taper of the raised portion 29 of the lumen 28. As these twosurfaces contact, they can form a closure at or near the second end 20of the male luer 10.

The substantially matched internal tapering surfaces of the raisedportion 58 of the tube 40 and the raised portion 29 of the lumen 28assist in providing closure of the female connector 92. Preferably arelatively fluid-tight closure is formed. The engagement between theraised portions 29 and 58 can also be created in a number of other ways.In some embodiments, the material of the flange section 58 and thematerial of the raised portion 29 of the lumen 28 are configured to fitclosely together, and are made of sufficiently compatible materials, toform a fluid-tight closure. In other embodiments, the flange section 58,and/or additional portions of the valve member 16, can be constructedfrom a deformable material that more closely follows the contours of theinternal surface of the lumen 28, and the lumen 28 need not have ataper. The sealing portion 20 is configured, in some embodiments, toprevent fluid from escaping from within the male luer connector 10. Whenthe valve member 16 engages the housing 23, the sealing portion 20 sitsbetween the middle portion 32 of the housing 23 and the tube 40. Whenfluid flows within the lumen 28 of the housing 23 and along the outersurface of the tube 40, the fluid is prevented from flowing past themiddle portion 32 by the sealing portion 20, and more particularly bythe rings 69 at either end of the sealing portion 20.

The sealing portion 20 is preferably held in position between thehousing 23 and valve member 16 by the protrusions 68 (see FIG. 6)configured to fit within the holes 36 in the middle portion 32 of thehousing 23. The protrusions 68 help to maintain the sealing portion 20in proper alignment.

With reference to the embodiment illustrated in FIG. 8, the structure ofan exemplary female connector 92 will now be discussed in furtherdetail. The female connector 92 can comprise an elongate body 72 havinga fluid passageway 74 therethrough, and the female connector 92 can havea tip 76 near its distal end. In some embodiments, the tip 76 of thefemale connector 92 has a radially extending surface 78 disposed on itsexternal surface. The female connector 92 can have a fluid conduitpositioned within the female connector 92. The fluid conduit is notincluded or required in all female connectors compatible with theconnectors 10 disclosed herein. Along a proximal inner surface 80 of thefemale connector 92, the fluid passageway 74 is preferably tapered suchthat the diameter of the fluid passageway 74 decreases in the distaldirection.

As shown in FIG. 8, the housing 23, the valve member 16, the resilientmember 18, and the sealing portion 20 are in an assembled configuration,in which the closing mechanism 56 forms a closing engagement between theflange section 58 and the interior of the lumen 28. In addition, thesealing portion 20 is in closing engagement between the valve member 16and the housing 23. Fluid from the passage 50 can flow through thewindows 54 of the tube 40 of the valve member 16. In this position, thewindows 54 communicate with the interior of the tip 22, but not yet withthe external environment. The lumen 28 is closed at its second end bythe closing mechanism 56 and at its first end by the sealing portion 20.

As shown in FIG. 8, the struts 42 of the valve member 16 extend throughslots in the housing 23 such that their ends extend to positions nearthe end of the shroud 24 toward the second end of the connector. Thesestruts 42 are configured to engage the proximal ends 84 of the femaleconnector 92 as the female connector 92 advances into engagement withthe closeable male luer 10.

In FIG. 8, the male and female luers are shown in an unengagedconfiguration. To engage the male luer 10 and female connector 92, theradially extending surface 78 of the female connector 92 are screwedinto the inner threads 26 of the male luer 10.

As shown in FIG. 9, the two luers can be threadedly engaged towards oneanother until the taper of the inner surface 80 of the female connector92 lies adjacent the correspondingly tapered external surface of the tip22. In other embodiments, the two luers can be threadedly engaged untilthe second end of the tip 22 forms a closure with a correspondingsurface (not shown) of the female connector 92.

As the male luer connector 10 and female connector 92 move towards eachother into threaded engagement, the proximal end 84 of the tip of thefemale connector 92 contacts the struts 42 of the valve member 16. Asthe male luer connector 10 and female connector 92 move further intothreaded engagement, the struts 42, and thereby the valve member 16, aremoved in the direction of the first end of the male connector by thefemale connector 92, displacing the valve member 16 relative to thehousing 23. Thus, the flange section 58 moves from the second end of thetip 22 of the housing 23 towards the first end of the male connector. Asthese two tapered surfaces separate, a space forms between the valvemember 16 and the housing 23 and fluid is allowed to pass through thehole 30 into the fluid passageway 74 of the female connector 92, or viceversa. When used with some embodiments of the female connector 92, aninternal fluid conduit contacts the second end of the valve member 16before the housing of the female connector 92 contacts the struts 42 toopen the male connector 10. In some embodiments, the closure remainsintact until the inner surface 80 of the tip of the female connector 92has formed a closing engagement with the outer surface of the tip 22 ofthe male luer 10. Thus, the passage 50 of the male luer 10 need not bein fluid communication with the external environment.

As the valve member 16 moves relative to the housing 23, the elasticmembers 64 (not shown in FIG. 9) of the resilient member 18 distend andexert a restoring force. As long as the female connector 92 engages themale luer 10, this restoring force can be resisted by the radiallyextending surface 78 of the female connector 92 contacting the innerthreads 26 of the housing 23. However, when the female connector 92 iswithdrawn from the male luer 10, the resilient member 18 returns thevalve element of the valve member 16 to closing engagement with thelumen 28.

Despite the relative movement between the housing 23 and the valvemember 16, the sealing portion 20 preferably maintains a fluid barrierbetween the outer surface of the tube 40 and the inner surface of thelumen 28. In some embodiments, the position of the sealing portion 20 ismaintained by the protrusions 68. In other embodiments, the sealingportion 20 can be positioned by gluing the outer surface of thedeformable material 70 to the inner surface of the lumen 28 of thehousing 23. Other means of fixing the sealing portion 20 can also beused.

As shown in FIG. 9, in the opened configuration, the fluid passageway 74of the female connector 92 can fluidly communicate with the passage 50of the valve member 16. Fluid can thereby flow from tubing 13 attachedto the male luer 10, into the passage 50 of the valve member 16, throughthe windows 54 into the lumen 28, out from the lumen 28 through the hole30 at the second end of the tip 22 into the fluid passageway 74 of thefemale connector 92, and vice versa. Fluid is prevented from escapingthe male luer 10 through the gap between the housing 23 and valve member16 by the sealing portion 20. A fluid-tight closure can also be formedbetween corresponding tapers of the tip 22 of the housing 23 and theinner surface 80 of the female connector 92.

Turning to FIG. 10, the connector 10 is displayed adjacent to acloseable female luer connector 210. In the sample embodimentillustrated here, the closeable female luer connector 210 comprises anouter housing 213, a void space 212, a fluid passageway 218, a fluidconduit 216 with one or more holes 215, a compressible seal element 214with a proximal surface 217, and a threaded engagement region 211. Thecloseable female connector 210 is positioned with its proximal endadjacent the second end 56 of the male connector 10. The threadedengagement region 211 of the closeable female connector 210 can conformto standard sizing for luer connectors, such as those that meet ANSIstandards. The compressible seal element 214 can be composed ofwater-impermeable, resilient material which can reduce in size when aforce is exerted upon it. The fluid conduit 216 can be composed of arigid material, such as polycarbonate plastic, which is capable ofresisting deformation when a force sufficient to compress the sealelement 214 is exerted upon the closeable female connector 210.

The fluid passageway 218 can place the fluid conduit 216 in fluidcommunication with the second end 219 of the closeable female connector210. At least one hole 215 in the fluid conduit 216 can be sealed by thecompressible seal element 214 to prevent the fluid passageway 218 frombeing in fluid communication with the void space 212 between thecompressible seal element 214 and the inner wall of the housing 213and/or with the exterior of the housing 213. The hole or holes 215 canbe sized appropriately small enough to permit fluid to pass between thefluid passageway 218 and the void space 212 at an appropriate flow rate.One such size for the hole or holes 215 is approximately 1 mm indiameter, although irregular shapes and other sizes can be used. Holesof at least about 1 mm or approximately 1 mm-3 mm, or less than about 1mm can also be used. The connector 10 can be engaged with a tubing 13containing a fluid.

With reference to FIG. 11, the connector 10 can be threadedly engagedwith the closeable female connector 210. The threaded region 211 of thecloseable female connector 210 can engage with the inner threads 26 ofthe male connector 10 to engage the connectors 10, 210, as illustrated.In the illustrated engagement, the luer tip 22 advances into thecloseable female connector 210 by compressing the compressible sealelement 214. As can be seen, the luer tip 22 contacts the compressibleseal element 214 on the proximal surface 217 of the compressible sealelement 214. The force exerted to engage the connectors 10, 210 and toengage the threaded regions 26, 211 is sufficient to compress the sealelement 214 to expose the holes 215 in the fluid conduit 216. With theseal element 214 compressed, the fluid passageway 218 is in fluidcommunication with the interior space of the luer tip 22.

As the luer tip 22 advances further into the closeable female connector210, the fluid conduit 216 contacts the end of the valve member 16towards the second end of the male connector. The valve member 16 isdisplaced towards the first end of the male connector by the contact andcontinued advancement of the luer tip 22. The resilient member 18 exertsa closing force in a direction towards the second end of the maleconnector on the valve member 16. As a result, the tip of the valvemember 16 towards the second end of the male connector generallymaintains contact with the fluid conduit 216 throughout the engagement.As the valve member is moved in a direction towards the first end of themale connector, the flange section 58 of the valve member 16 separatesfrom the interior surface of the housing 23 through which the hole 30passes. As a result, the windows 54 are opened to fluid communicationwith the closeable female connector 210. The compressed seal element 214inhibits fluid flow into the interior of the closeable female connector210 beyond the luer tip 22. In this configuration, fluid can flow fromthe tubing 13 at the end of the valve member 16 toward the second end ofthe male connector and into the tube 40 through the windows 54 into theinterior of the lumen 28, out the hole 30 in the luer tip 22, into theinterior of the outer housing 213 of the closeable female connector 210,in the holes 215 of the fluid conduit 216 and into the fluid channel 217in the interior of the fluid conduit 216. Thus, the second end of theconnector 210 is placed in fluid communication with the proximal end 219of the closeable female connector 210. Additionally, the sealing portion20 preferably maintains a fluid barrier between the outer surface of thetube 40 and the inner surface of the lumen 28, confining the flow offluid towards the closeable female connector 210. When the surface ofthe valve member towards the second end of the connector is directlycontacted by a female connector member such as the fluid conduit 216,the struts 42 may not be engaged by the female connector.

The connectors 10, 210 can be threadedly disengaged. Duringdisengagement, the force exerted by the resilient member 18 can returnthe connector 10 to its pre-engaged state by directing the valve member16 to engage the flange section 58 of the end of the valve member 16toward the second end of the male connector with the internal surface ofthe luer tip 22. Likewise, the resilient material of which thecompressible seal is composed can return to its shape in the closedposition, and the proximal surface 217 can seal the proximal tip of thecloseable female connector 210.

Referring now to FIG. 12, the connector 10 can be engaged with a syringe250. In FIG. 12, the syringe 250 and connector 10 are displayed adjacentto each other. The syringe can comprise a male luer connector 252, aplunger 258, a reservoir 260, and convenient finger anchors 262. Theluer connector 252 can further comprise an internally threaded shroud254 and a syringe luer tip 256. In the illustrated embodiment of theconnector 10, a threaded surface 150 is disposed on the outside surfaceof the first end of the valve member 16.

With reference now to FIG. 13, the connector 10 can be threadedlyengaged with the syringe 250. The shroud 254 can engage with the end 16of the valve member toward the first end of the connector to connect theconnector 10 to the syringe 250. The reservoir 260 of the syringe 250can be placed in fluid communication with the tube 40 interior to thevalve member 16.

Turning to FIG. 14, the engagement illustrated in FIG. 13 is shown in across-sectional view. The syringe 250 is threadedly engaged with theconnector 10 by the engagement between the shroud 254 and the threadedsurface 150 of the valve member 16. The luer tip 252 of the syringe 250is extended into the tube 40 of the valve member 16. The reservoir 260of the syringe, shown here with a fluid in the reservoir 260, is influid communication with the interior of the valve member 16. The fluidcan pass through the tube 40 and towards the luer tip 22 of theconnector 10. In the illustrated embodiment, the fluid cannot exit theconnector 10 out its male luer tip 22 because the flange section 58 isin contact with the interior surface of the lumen 28. Accordingly, thehole 30 in the tip of the housing 23 towards the second end of theconnector is blocked by the valve member 16. In order for the syringe250 and connector 10 to transition from the stage shown in FIG. 12 tothe stage shown in FIG. 14, the valve member 16 may need to betemporarily opened to release air (as described in more detail below).

Referring to FIG. 15, the connector 10 is shown adjacent to and betweena syringe 250 and a hypodermic needle with sheath 270. The syringe 250,like that of FIG. 12, can comprise a male luer connector 252, a plunger258, a reservoir 260, and convenient finger anchors 262. The luerconnector 252 can further comprise an internally threaded shroud 254 anda syringe luer tip 256. The needle with sheath 270 can comprise ahousing 266 with raised tabs 264 on the engagement end and a needle 268.

With reference to FIG. 16, the connector 10 is shown threadedly engagedwith both the syringe 250 and needle with sheath 270. The threadedsurface 150 of the valve member 16 of the connector 10 can engage withthe threaded shroud 154 of the syringe 250. Accordingly, the luer tip256 can protrude into the tube 40 of the valve member 16. Similarly, theraised tabs 264 can engage with the inner threads 26 of the shroud 24 ofthe connector 10. The luer tip 22 of the connector 10 can protrude intothe housing 266 of the needle sheath.

In FIG. 17, the engagement shown in FIG. 16 is illustrated in across-sectional view. The connector 10 is engaged by a syringe 250 and aneedle with a sheath 270. The syringe 250 is threadedly engaged with thethreaded surface 150 of the valve member 16 of the connector 10. Theneedle with sheath 270 is threadedly engaged with the inner threads 26of the shroud 24.

The luer tip 256 of the syringe 250 protrudes into the tube 40 of thevalve member 16. The reservoir 260 of the syringe 250 is in fluidcommunication with the tube 40 of the valve member 16 through the luertip 256.

The connector 10 is engaged with the needle with a sheath 270. Thehousing 266 of the needle with sheath 270 has raised tabs 264 near itsproximal end. The raised tabs 264 threadedly engage the inner threads 26of the shroud 24 of the connector 10. As the luer tip 22 advances intothe housing 266 of the needle 268, the proximal end of the housing 266can contact the struts 42 of the valve member 16. When the needle withsheath 270 is fully engaged with the connector 10, the valve member 16has been displaced a distance which separates the flange section 58 fromthe tapered interior wall of the lumen 28 sufficiently to permit fluidto flow out the windows 54 of the valve portion 16. The fluid can thenflow out the hole 30 in the end of the luer tip 22 and into the housing266 of the needle with sheath 270. The hollow needle 268 permits thefluid to flow from within the housing 266 out the distal tip of theneedle 268. The sealing portion 20 preferably maintains a fluid barrierbetween the outer surface of the tube 40 and the inner surface of thelumen 28, confining the fluid in the lumen and the direction of flowtoward the hole 30 in the luer tip 22. Thus, at this stage, the syringe250 is in fluid communication with the distal tip of the needle 268. Aswas previously illustrated in FIGS. 13 and 14, in some embodiments, theconnector 10 will generally not permit fluid to flow out of the syringe250 without a component engaged with the second end 14 of the connector10. The component illustrated in FIGS. 15-17 is a needle with a sheath270; however, other components, such as those which permit fluid flowand possess a female luer engagement portion, can also be used.

FIG. 18A displays a perspective view of another embodiment of acloseable male luer. The rotatable connector 300 is comprised of ahousing 310, an internal passageway 322 and a seal element 330. Thehousing is further comprised of a luer tip 312, a luer receiver 316 atthe first end of the connector 300, an engagement portion 318, amanipulation portion 320, and a raised portion 340. The seal element 330can have an opening 350 along its face 314 in a transverse direction.The internal passageway 322 can extend from the luer receiver 316 to theluer tip 312. The housing 310 can be composed of a water-impermeablematerial, such as a polycarbonate plastic. The housing 310 can also becomposed of a hydrophobic plastic. Other examples of materials suitablefor construction of the housing 310 are glassed-filled GE Valox 420 orpolypropylene. Depending on the application, many other materials canalso be used.

The housing 310 illustrated is configured to receive a male luer tip atthe luer receiver 316 by threadedly engaging the male luer at itsengagement portion 318. The receiver 316 can conform to ANSI standardsfor a luer receiver. The illustrated manipulation portion 320 has twotabs extending radially from the central axis of the housing 310. Themanipulation portion 320 is configured to aid the user in grasping androtating the connector 300.

The housing 310 illustrated is also constructed to provide a closeablemale luer at its second end. The luer tip 312 at the second end can beconstructed to ANSI standards for a male luer tip. The luer tip joinsthe main body of the housing 310 at the raised portion 340. The raisedportion 340 is constructed to inhibit the luer tip 312 from advancingtoo far into a luer receiver. The housing 310 can also have a recessedportion 342 behind the raised portion 340. The luer tip 312 can alsohave a seal element 330 which has a face 314 towards the second end ofthe connector. The seal element 330 can be any water-impermeable,resilient material, including without limitation, silicone. Theselection of the material for construction of the seal can beaccomplished by one skilled in the art. The luer tip 312 can tapersmaller in a direction from the raised portion 340 as it approaches itssecond end.

The seal element 330 can also have an opening 350 in the face 314 towardthe second end of the connector prior to engagement with any othercomponent. The opening 350 can be a slit in a transverse direction tothe longitudinal axis of the housing 310. The opening 350 can becentered across the face 314, or located in another position on the face314. The seal element 330 can cover the entire second end of the luertip 312, or only a portion thereof. The seal element 330 can be attachedto the housing by an overmolding process, among other attachmentmethods. In such an overmolding process, the housing 310 can be formedby injection molding in a first step, and then in a second step, thehousing 310 can be re-inserted into a mold (or remain in a mold) and anappropriately sized molding pin (not shown) can be inserted through awider end of the housing 310, such as the second end. Silicone materialcan then be injected into the mold to form the seal element 330. Inother embodiments, the seal element 330 can be glued or otherwiseadhered into the housing 310.

As can be seen from the illustrated embodiment in FIG. 18A, the sealelement 330 can inhibit fluid from flowing through the housing 310 whenthe luer tip 312 is not engaged with another component. Thus, when afluid-containing component (not shown) with a male luer connector isconnected to the luer receiver 316, the connector 300 can be used tocontrol flow of fluid through its luer tip 312. For example, when afluid-containing component such as a syringe is engaged with theconnector 300, fluid is permitted to fill the housing 310 of theconnector 300 by flowing through the internal passageway 322, but theseal element 330 can substantially inhibit flow of fluid out the luertip 312. If the interior space of the housing is filled with air oranother gas before the fluid enters, the connector 300 may need to beopened to allow the air or other gas to escape before the fluid canenter. In some embodiments, as described in detail below, the internalsurface of the seal element 330 can be adapted to increase theresistance against the widening of the opening 350, which could allowfluid to escape when the fluid (not shown) exerts a pressure against theseal element 330 from the internal passageway 322. Thus, the connector300 inhibits flow of fluid from a fluid-bearing component when theconnector 300 is attached to the male luer of the fluid-bearingcomponent without another component connected to the luer tip 312 of theconnector 300.

In some modes of use, the opening 350 on the face 314 of the sealelement 330, normally closed in the position shown, can be opened whenthe luer tip 312 comes in contact with a suitable female connector, suchas a Clave® connector sold by ICU Medical, San Clemente, Calif. Anillustrated engagement of this configuration is discussed in detailbelow. The engagement can be achieved in many other ways, and with manyother structures, including connectors other than the Clave® connector.

FIG. 18B is a cross-sectional view of the connector 300 illustrated inFIG. 18A. The connector 300 can have an internal passageway 322 whichconnects the luer receiver 316 to the luer tip 312. The engagementportion 318 can be configured to receive an internally threaded shroudof a male luer connector (see FIG. 19). The manipulating portion 320 canextend radially away from the internal passageway 322, as shown. Theseal element 330 can extend along at least part of the internalpassageway 322, and can be disposed across at least part of the secondend of the connector 300. The seal element 330 can extend beyond the endof the luer tip 312. The seal element 330 can have a cross-sectionalarea approximately equal to the housing 310 at the end of the luer tip312. In those embodiments where the luer tip 312 and seal element 330are generally circular, the outside diameter of the seal element 330 canbe equal to the outside diameter of the luer tip 312. The seal element330 is not confined to a circular shape (nor are any other structuresdisclosed herein), and other shapes can be used. In other embodiments,the seal element 330 does not extend beyond the end of the housing 310towards the second end of the connector 300, but can have a maximumouter dimension equal to that of the inner dimension of the luer tip312. The seal element 330 can have a closing portion 324. The closingportion 324 can permit fluid flow through the seal element 330 of theconnector 300, but is biased to generally close the opening 350 in theseal element 330. The structure of the closing portion 324 can beadapted to resist permitting fluid (not shown) from exiting the opening350 when the luer tip 312 is not engaged with another component, asdescribed in further detail below.

As can be seen in FIG. 18C, which is a detail of the cross-sectionalview presented in FIG. 18B, the seal element 330 can comprise the entireface of the second end of the connector 300. In other embodiments, theseal element 330 may not extend beyond the housing 300. The internalpassageway 322 can extend to the seal at the second end of the connector300.

FIG. 19 illustrates a perspective view of the connector 300 adjacent asyringe 360. As in previous descriptions, the syringe can comprise amale luer connector 362, a fluid reservoir 370, a plunger 374, andfinger anchors 372. The luer receiver 316 of the connector 300, whichcan be of appropriate size and shape to engage with standard luerconnectors, is positioned to receive the luer tip 364 of the syringe360. The internal threads 368 of the shroud 364 of the syringe 360 areproperly aligned to threadedly connect with the engagement portion 318.In this way, the receiver 316 can engage the luer connector 362 andconnect the connector 300 to the syringe 360. Before engagement of thesyringe 360 with the connector 300, the fluid within the reservoir 370is not inhibited from exiting the luer tip 364 by any physicalcomponent.

Referring now to FIG. 20, a perspective view of the connector 300threadedly connected to a syringe 360 is shown. The connector 300 can beconnected to the syringe 360, or other medical implement, by many othermeans, such as glue, adhesive, solvent, ultrasonic welding, epoxy,interference fits, mechanical connections, and/or unitary constructions.The receiver 316 (not shown) contains at least part of the luer tip 364of the syringe 360. The luer tip 364 extends at least partially into theinternal passageway 322. The threaded engagement portion 318 is engagedwith the internal threads 368 of the shroud 364 of the syringe 360.Fluid from the reservoir 370 can then flow freely within the housing 310of the connector 300, by way of the internal passageway 322. If theinterior space of the housing is filled with air or another gas beforethe fluid enters, the connector 300 can be opened to allow the air orother gas to escape before the fluid can enter. In some cases, thehousing 310 of the connector 300 may be filled with a gas, such as air.Before the fluid enters the housing 310, the connector may need to beopened to allow the gas to escape before the fluid can flow. The sealelement 330 inhibits fluid from leaving the connector 300. The luer tip312 of the connector 300 can be used to connect the connector-syringe300, 360 combination to other components for controlled fluid transfer.The connector 300 can also be formed integrally with the syringe 360(not shown), such that the housing 310 of the connector is formed by thefluid-delivery end of the syringe. During use of this combinationconnector-syringe, the male luer tip 312 of the connector 300 can, ineffect, replace the luer tip 364 of the syringe for connection purposes.

Certain medications, such as chemotherapy medications, are contacttoxins, and avoiding exposure to the skin is desirable. Such medicationsare often stored in a syringe with a hypodermic needle, such as depictedin FIGS. 15 and 16. Under certain conditions, without the use of acloseable male luer connector, it can be possible for the toxic fluid toflow out of the syringe. Even if steps are taken to avoid accidentalfluid flow, such as orienting the syringe with attached needle such thatgravity aids the retention of the medication within the syringe, themedication can also vaporize and seep out of the hypodermic needle in agaseous state. The use of a closeable male luer between the syringe andhypodermic needle inhibits the uncontrolled flow of medication, in bothliquid and gaseous states. Accordingly, risk of accidental exposure tosuch toxic medications is minimized.

Referring now to FIG. 21, the closeable male luer connector 300 isillustrated in another embodiment, wherein an internally threaded shroud380 is disposed on the housing 310. The shroud 380 at least partially orentirely encircles the housing 310 at approximately the recessed portion342 (visible in FIG. 18A). In some embodiments, the shroud 380 is notattached to the connector 300, and instead can rotate freely about thelongitudinal axis of the connector 300. The raised portion 340 (visiblein FIG. 18A) can inhibit the movement of the shroud 380 towards the luertip 312 of the connector 300. Additionally, the manipulation portion 320of the connector 300 can inhibit the movement of the shroud 380 towardsthe luer receiver 316. The shroud 380 can be threaded consistent withANSI specifications for luer connectors. The shroud 380 can assist theluer tip 312 in forming a connection between the connector 300 and othercomponents (not shown).

With reference now to FIG. 22A, the cross-section of a closeable maleluer connector 400 with a continuously tapering internal passageway 402is illustrated. The housing's 404 tapering internal passageway 402permits for varied injection molding techniques of manufacture. Forexample, if the taper is wider at an end with a luer receiver 406, amolding pin can be tapered in a corresponding manner to closely fitagainst the wall of the internal passageway 402, producing a seal 408that is shorter than the seal illustrated in FIG. 18B.

With reference to FIG. 22B, the seal 408 in the illustrated embodimenthas a closing portion 412 similar to that of the closing portion 324 inFIG. 18B. In addition, the internal surface of the seal 408 can beadapted to increase resistance against permitting fluid from exiting theopening 410 when a fluid (not shown) in the internal passageway 402exerts a pressure against the seal 408. The internal surface of theclosing portion 412 can include slanted surfaces against which suchfluid presses to urge the opening 410 more tightly closed.

Turning to FIG. 23A, a side view of another embodiment of the connector400 of FIG. 22A is displayed. An internally threaded shroud 420 isdisposed about the outer surface of the housing 404.

As can be seen in FIG. 23B, the housing 404 can have a raised portion424 which inhibits axial movement of the shroud 420 toward the luer tip416. The housing 404 can also have a manipulation portion 418 whichextends radially outwardly from the longitudinal axis of the connector400. The housing 404 also has an internal passageway 428 extending fromthe luer receiver 414 to the seal element 430. The manipulation portion418 can inhibit movement of the shroud towards the luer receiver 414 ofthe connector 400. The manipulation portion can also be a convenientplace for the user to place his or her fingers while turning theconnector 400. Additionally, there can be a recessed portion 426 of theconnector 400. The recessed portion 426 can be a portion of theconnector 400 with a smaller outer diameter than the outer diameter ofthe raised portion 424 or the manipulation portion 418. The shroud 420can be disposed on the connector 400 such that a narrow portion of theshroud 420 encircles the connector 400 about the recessed portion 426.The shroud 420 can be unaffixed to the housing 404 and thus free torotate. The internal threads 422 of the shroud can conform to ANSIstandards for luer connectors, allowing the shroud to assist the luertip 416 in engaging the female connector of another component (notshown).

FIG. 23C depicts the closeable male luer connector 400 of FIG. 23B inthe proximity to a suitable female connector 450, such as a Clave®connector sold by ICU Medical, San Clemente, Calif. The female connector450 is similar to that illustrated in FIG. 10.

FIG. 23D illustrates an engagement between the male luer connector 400and female connector 450. The internal threads of the shroud 420 canengage with a threaded region 451 of the female connector 450. The luertip 416 of the male luer connector 400 can advance into the femaleconnector 450 by compressing a compressible seal 454. As the maleconnector 400 advances, a stationary fluid conduit 456 of the femaleconnector 450 can penetrate the opening 448 in the seal element 430 ofmale connector 400. The fluid conduit 456 can advance far enough intothe male connector 400 that the holes 455 advance into the internalpassageway 428 of the male connector 400. Once the holes 455 of thefemale connector 450 are disposed within the internal passageway 428 ofthe male connector, fluid can flow from the luer receiver 414 of themale connector 400 through the internal passageway 428 of the maleconnector 400 to the holes 455 of the fluid conduit 456 of the femaleconnector 450. The fluid can then flow through the holes 455 and into afluid conduit 458 of the female connector 450. Thus, fluid can flow fromthe first end of the male connector 400 to the distal end of the femaleconnector 450 when the two are engaged. When the connectors 400, 450 aredisengaged, the fluid conduit 456 withdraws from the internal passageway428 and the seal element 430 closes, thereby inhibiting fluid flowthrough the male connector 400. Additionally, the compressible seal 411of the female connector 450 returns to its original position, andinhibits flow through the holes 455 in the fluid conduit 456.

With reference now to FIG. 24A, a closeable male luer connector 500 isdisplayed in a perspective view. The connector 500 has a housing 510 anda seal 514. The housing is comprised of a manipulation portion 512. Inthis exemplary illustration, the manipulation portion 512 includes wings516. The wings 516 are adapted to provide a place for the user to graspand rotate the housing 510 of the connector 500.

Referring now to FIG. 24B, the connector 500 of FIG. 23A is shown incross-section. The wings 516 are shown as extending outward from thelongitudinal axis of the connector 500 and towards the luer receiver 518of the connector. The internal passageway 520 of the housing 510 has acontinual taper, as described in the embodiment of the connector 400 inFIG. 22A.

Turning to FIG. 25A, a side view of a closeable male luer connector 600is illustrated. The connector 600 has a housing 610, a seal element 614,and a shroud 620. The housing comprises an internal passageway 640, aluer tip 612, and a manipulation portion 616. The manipulation portioncan be constructed to comprise two wings 630, as described in FIG. 24A.The shroud can have internal threading 622, and such threading can beconstructed to comply with ANSI specifications for luer connectors. Theseal element 614 can be biased closed when not engaged.

With reference now to FIG. 25B, a cross-sectional view of the connector600 from FIG. 25A is displayed. The shroud 620 can encircle the housing610 at a recessed portion 652 of the housing 610. A raised portion 650can inhibit motion of the shroud 620 in the direction of the second endof the connector 600 while the manipulation portion 616 can inhibitmotion of the shroud in the direction of the first end of the connector600. The internal threading 622 of the shroud 620 can be used to engageother components (not shown) when used in conjunction with the luer tip612. The continuously tapering internal passageway 640 hascharacteristics that assist in injection molding as discussed withregard to FIG. 22A.

Referring to FIG. 26A, a perspective view of a closeable male luerassembly 725 comprising a closeable male luer 700 and a flexiblyconnected female luer connector 750 is displayed. The closeable maleluer 700 can embody any number of the aspects and features described inthis application. The female luer connector 750 is adapted to receive astandard male luer connector (not shown). The female luer connector 750is located adjacent the male luer connector 700 and flexibly connectedto it. The female luer connector 750 comprises an internal passageway752, a luer receiver 754, and an engagement portion 756. The internalpassageway 752 places the luer receiver 754 in fluid communication withan internal passageway of the closeable male luer connector 700. Thecloseable male luer connector 700 can be attached to the female luerconnector 750 through a flexible segment 760. In some embodiments, sucha segment 760 can include an accordion-like flexible portion ofresilient material. In other embodiments, a straight, flexible materialcan be used. In other embodiments, both a flexible outer segment and aflexible tube can be used to connect the closeable male luer 700 withthe female luer 750.

The flexible segment 752 permits the user to orient the female connector750 of the assembly 725 in a different attitude than that of thecloseable male luer connector 700. As an example, the closeable maleluer 700 can remain stationary against a patient's arm while the femaleconnector 750 is angled away from the arm to assist in easy connectionwith a syringe or other component (not shown). By flexibly connectingthe closeable male luer 700 to the female luer connector 750, the momentgenerated by moving the female luer connector 750 is accepted at a pointbetween the two components of the assembly 725 and is less likely to betransmitted to another component (not shown) attached to the closeablemale luer connector 700. Such a component could include an I.V. site,where angling of the connection could result in harm to the patient.Moreover, the moment will be less likely to bend and/or dislodge the tipof the tube 40 from the interior of the lumen 28 (see, e.g., FIG. 28).

FIG. 26B illustrates another embodiment of a closeable male luerassembly 800 comprising a closeable male luer connector 825 and aflexibly connected female luer connector 850. The connectors 825, 850and their components are similar in many respects to the embodimentdepicted in FIG. 26 and can embody any number of the aspects andfeatures described above. The closeable male luer connector 825 and thefemale luer connector 850 are flexibly connected by a connecting member860. The connecting member 860 places the connectors 825, 850 in fluidcommunication. The connecting member 860 illustrated here comprises anaccordion-shaped plastic conduit. The connecting member 860 isconfigured to permit the closeable male connector 825 and the femaleluer connector 850 to be positioned at different angular orientations.By way of example, the closeable male luer connector 825 can remainstationary while the female luer connector 850 can be positioned at anangle to the closeable male luer connector 825. In another example, thefemale luer connector 850 can remain stationary while the closeable maleluer connector can be positioned at an angle to the female luerconnector 850. In yet another example, the closeable male luer connector825 and the female luer connector 850 can both be placed at an angle.

FIGS. 27-32 illustrate another embodiment of a closeable male luerconnector 900 with a male end 902 and a female end 904. In somerespects, the connector 900 is similar in structure and assembly toother embodiments disclosed and illustrated herein. For example, theconnector 900 can include an outer housing 906, a shroud 908, aresilient member 910, an internal valve member 912, and an internalsealing portion 914. All of the descriptions, illustrations, andfeatures of each embodiment disclosed herein can be applied to otherembodiments disclosed herein. As described below, the connector 900 canbe effective in preventing or minimizing the potential dripping of fluidout of the male end 902 when the male end 902 is in the process ofclosing.

As illustrated in FIGS. 28 and 29, the valve member 912 can have aninternal fluid passageway 916 with a varying cross-sectional area. Insome embodiments, the valve member 912 does not have an internalpassageway and fluid instead flows around the valve member 912. Asshown, the cross-sectional area of a region 918 of the passageway 916positioned generally within the male end 902 of the housing 906 can berelatively narrow; the cross-sectional area of a region 920 of thepassageway 916 positioned generally in the middle of the connector 900can be wider and have a tapering wall as shown; a region 922 of thepassageway 916 positioned closer to the female end 904 can have a largerinternal volume than the second region 920; a region 924 of thepassageway 916 can be connected to region 922 by way of a narrow opening926; and a region 928 can be connected to region 924. In someembodiments, region 928 can be connected to region 924 by way of anarrow opening (not shown). In some embodiments, the connector 900 canalso include one or more struts 921 to facilitate opening the connector900.

As discussed above, the region 928 and the female end 904 of the housing906 can be structured to include one or more of the components of theclosing female end of connectors 21, 210 (and/or any components fromother types of closing female connectors) to permit the female end 904of the connector 910 to be selectively opened or closed to fluid flow.

An internal conduit 932 can partially or completely surround the region924 of the internal fluid passageway 916. The conduit 932 can be securedto a base 934, and the base 934 can be secured to the female end 904 onone side and to an intermediate portion 936 on the other side. In theillustrated embodiment, the outer perimeter of the base 934 extends tothe outer perimeter of the housing 906, but it can be configured in manyother ways. The intermediate portion 936 can be secured to the remainderof the housing 906. On the end of the valve member distal from the maleend 902, an internal conduit 938 can surround region 922 of the fluidpassageway 916. In the illustrated embodiment, the internal conduit 938of the valve member is larger in cross-sectional area and in internalvolume than is the internal conduit 932 surrounding region 924. A sealelement 940 can be positioned in a region of interface between internalconduits 932, 938 to prevent or minimize leakage of fluid out of thepassageway 916 at such interface, while permitting relative axialmovement between internal conduits 932, 938. In some embodiments,internal conduits 932, 938 are rigid and do not flex or bend undernormal operating conditions. In some embodiments, outer housing portions906, 908, 934, and 936 are molded into a single, contiguous housing. Inother embodiments, they may be molded separately and later joinedtogether to form the housing.

As shown in FIG. 30, the female end 904 of the connector 900 can beconnected to a male portion 944 of another medical implement such as asyringe 942. In this and in all other embodiments disclosed herein, anyof a wide variety of other types of medical implements can be attachedto the disclosed connectors. In the configuration illustrated in FIG.30, the connector 900 and syringe 942 are filled with a fluid, such aschemotherapy medication. The fluid cannot escape from the connector 900under normal conditions because it is impeded on one side by theinterface between the valve member 912 and the male end 902 and on theother side by the fluid pressure or structure within the medicalimplement 942.

As illustrated in FIG. 31, when the valve member 912 is urged away fromthe male end 902 upon attachment of connector 900 to another medicalimplement (such as the female connector housing 946 of a plastic IVtube), internal conduit 938 moves in the direction of the female end904, overlapping at least a portion of internal conduit 932. Fluid isthen permitted to flow between medical implements 942, 946 by way of theconnector 900. In this second, opened configuration or position, region922 is smaller than it was in the first, closed configuration orposition (see FIG. 30). On the other hand, regions 918, 920, and 928generally remain about the same size. In some embodiments, includingsome in which the valve member 912 does not have an internal flow path,a region of changing volume within the connector 900 can be provided byoverlapping structures in sliding engagement without directing the fluidflow through the valve member 912. For example, if the valve member issolid, it can be advanced into and withdrawn from conduit 932, and asuitable opening (e.g. in conduit 932 or base 934) can permit fluid toflow through the housing 906 to the male end 902. In some embodiments,including some in which the valve member 912 does not have an internalflow path, the valve member could include a sleeve that can beoverlapped over conduit 932 and a suitable opening (e.g. in conduit 932or base 934) can permit fluid to flow through the housing 906 to themale end 902.

In some embodiments, upon disconnection of the medical implement 946from the connector 900, the male end 902 can automatically close whenthe valve member 912 moves within the housing 906 toward the male endunder the biasing force of the resilient element 910. In certaincircumstances, the movement of a valve member within a fluid passagewaycould push a small volume of fluid within the male end through the maleopening and outside of the connector, resulting in a drip induced by theclosing of the valve. However, in the illustrated embodiment, such adrip is generally prevented or minimized.

As shown in FIG. 32, as the medical implement 946 and the valve member912 advance in the direction of arrow 950, the region of overlap betweeninternal conduits 932, 938 can decrease and the volume of region 922 ofthe fluid passageway 916 can increase. The volume of region 922 caneventually return to its approximate original volume in the closedconfiguration (see FIG. 30). The expanding volume of region 922 duringclosure of the male luer urges fluid from elsewhere in the passageway916 to move into region 922.

In some embodiments, the growing void in region 922 cannot be filled byfluid between region 922 and the syringe or other medical implement 942because the movement of such fluid is prevented by structures in themedical implement 942 (such as the stem seal within the syringe, notshown). Moreover, in some embodiments, such as that shown in FIG. 32,the opening 926 between region 922 and the end of the female connector904 is substantially smaller than the openings 952, 954 between regions922, 920, and the remainder of the fluid passageway 916 within the maleluer. In this configuration, there can be less fluid resistance withinthe male end 902 than within the female end 904. In some embodiments,the cross-sectional area of opening 926 is less than one-half thecross-sectional area of opening 954. In some embodiments, thecross-sectional area of opening 926 is less than one-quarter thecross-sectional area of opening 954. In some embodiments, thecross-sectional area of opening 926 is less than one-fifth thecross-sectional area of opening 954. This configuration makes it morelikely that fluid will be drawn from the male end 902 into the connectorrather than from the female end 904.

As a result of the void in region 922, fluid between the valve member912 and the internal wall of the male end 902 is pulled back within thebody of the connector 900 toward region 922 rather than being pushed outof the male opening. As the connector 900 closes, the increasing volumein the interior of the connector 900 tends to draw fluid in from theopening 948 rather than permit the fluid to be expelled. In theillustrated embodiment, this is achieved in part by providing across-sectional area of the region 922 that is substantially larger thanthe cross-sectional area of opening 948. The volume in region 922increases faster than the volume in 948 decreases as the valve member912 moves into the closed position. In some embodiments, the rigid wallsof the overlapping internal conduits 938, 932 can sustain extendedrepeat movement and usage with minimal wear. The walls of theoverlapping internal conduits 938, 932 generally do not deform orweaken, which could otherwise affect the size of the void created insideof the connector during closure. Moreover, the walls of the overlappinginternal conduits 938, 932 generally do not bulge or buckle underrelatively high fluid pressures within the connector, nor do theygenerally permit the valve member 912 to become misaligned within theinternal cavity of the housing 906 under most conditions.

In some embodiments of a closeable male luer connector disclosed herein,it may be difficult to “prime” the connector (i.e., replace air insideof the connector with fluid) without forcing air into one or moremedical implements to which the connector is attached. In suchembodiments, a separate priming cap can be attached to the male end ofthe connector. The priming cap can be structured in many different ways.

FIG. 33 provides an example of a priming cap 956 that can be used with acloseable male luer connector 900. A suitably configured priming cap canbe used with any of the embodiments of the male luer connectorsdisclosed herein. In some embodiments, the priming cap 956 can include astructure to open the closeable male luer connector 900 (such as a rigidinternal conduit, not shown, for pushing against the valve member 912 ora female end 962 with a housing wall 960 configured to abut the strutsinside of the shroud 908), permitting fluid to escape from inside of thecloseable male luer connector 900. The priming cap 956 can also includean internal fluid passageway (not shown) through which fluid from theopened male luer connector 900 can pass. The fluid passageway can leadto an exit bore 964. The priming cap 956 can also include a filter 958through which the escaping air can pass but not the advancing liquid. Inthe illustrated embodiment, the filter 958 is positioned in the exitbore 964. Thus, the air can be evacuated from the male luer connector900, through the priming cap 956, and out of the exit bore 964, whilethe liquid generally remains inside the male luer connector 900 andpriming cap 956. When priming is completed, the priming cap 956 can beremoved and discarded, which automatically closes the closeable maleluer connector 900, and another medical implement can be attached to thecloseable male luer connector 900. Many other structures andconfigurations of priming caps also can be used.

FIGS. 34-35 illustrate another embodiment of a closeable male luerconnector 900 a with a male end 902 a, a housing 906 a, a female end 904a, and a resilient member 910 a, and struts 921 a. As shown in FIG. 35,an end 913 a of the valve member 912 a near the tip of the male end 902a can have a first surface 915 a with a larger cross-sectional surfacearea than a second surface 917 a configured to abut an internal side ofthe tip of the male end 902 a. This configuration can assist in creatingan interface that is further resistant to leakage from the male luerconnector 900 a through the male end 902 a. In the embodiment of FIG.35, the internal conduit 938 a is smaller in cross section than is theinternal conduit 932 a. The relative moment between conduits 932 a, 938a produces a change in the volume of region 922 a, as in the embodimentillustrated in FIGS. 27-32. A resilient seal 940 a prevents or minimizesfluid leakage at the interface between the conduits 932 a, 938 a. Whenthe closeable male luer connector 900 a is in the first, closedposition, as shown, the volume of region 922 a is larger than when thecloseable male luer connector 900 a is in the second, opened position.Internal passageway 916 a may have straight walls such that thepassageway 916 a maintains a relatively constant cross-sectional area.In some embodiments, the walls of passageway 916 a may include a taper.In many respects, the closeable male luer connector 900 a functions in asimilar manner to the closeable male luer connector 900 of FIGS. 27-32.

FIGS. 36-37 illustrate another embodiment of a closeable male luerconnector 900 b with a male end 902 b, a housing 906 b, a female end 904b, and a resilient member 910 b. This embodiment also includes anactuator 925 b for manually opening and closing the male luer connector900 b. Many different types of manual actuators can be used, includingthose employing springs, buttons, levers, and other structures. In theillustrated embodiment, the valve member 912 b includes at least onelateral side 927 b that can be contacted by the fingers and advancedtoward either the male end 902 b or toward the female end 904 b. In theillustrated embodiment, the valve member 912 b includes struts 921 bwithin the shroud 908 b. As such, when the lateral side 927 b is movedtoward the male end 902 b, the male luer connector 900 b can be closedunless the male luer connector 900 b is attached at its male end 902 bto another medical implement. When the lateral side 927 b is movedtoward the female end 904 b, the male luer connector 900 b can beopened, even when another medical implement has not yet been attached atthe male end 902 b of the connector 900 b. As shown in FIG. 36, theexterior surface of the actuator 925 b can be serrated or otherwisetextured to avoid slipping of the fingers, and the exterior surface ofthe actuator 925 b can be positioned slightly below the outer perimeterof the housing 906 b to avoid unintentional opening or closing of theconnector 900 b, especially during installation or other movement of theconnector 900 b. In some embodiments, the valve member 912 b may notinclude struts within the shroud 908 b.

The actuator 925 b, or some other structure for manual opening andclosing of the connector 900 b, can be particularly advantageous in someapplications during priming of the closeable male luer connector 900 b.It allows for the connector 900 b to be opened while air within theconnector 900 b is evacuated into the environment before the connector900 b is attached to another implement (which would otherwise cause theevacuated air to be forced into such other implement). A priming cap maynot be necessary when manual means are provided for opening and closingthe connector 900 b.

FIGS. 38-39A illustrate another embodiment of a closeable male luerconnector 900 c with a male end 902 c, a housing 906 c, a female end 904c, and a resilient member 910 c. This embodiment also includes aninternal structure for impeding or halting the flow of fluid. Aresilient covering 933 c is positioned generally within region 922 c.The covering 933 c can include a forward surface 935 c, which isgenerally flat in the illustrated embodiment, a slit 931 c, and asidewall 937 c. The sidewall 937 c can be corrugated to facilitate axialcompression of the covering 933 c. The sidewall 937 c can be connectedto a seal element 940 c as shown, or the sidewall 937 c can be attachedto a forward end 971 c of the conduit 932 c. The conduit 932 c can be influid communication with a secondary conduit 939 c.

As shown in FIG. 39A, when the valve member 912 c is moved toward thefemale end 904 c, an internal shoulder 941 c on the valve member 912 ccomes into contact with the forward surface 935 c of the covering 933 c,causing the covering 933 c to compress or otherwise move in thedirection of the female end 904 c. On the other hand, the secondaryconduit 939 c generally remains stationary and abuts against the otherside of the forward surface 935 c of the covering 933 c. The opposingforces exerted against the covering 933 c by the shoulder 941 c and theconduit 939 c cause the covering to bend and the slit 931 c opens up topermit fluid flow through the connector 900 c. The selective opening ofthe covering 933 c (or another type of internal fluid impedancestructure) can be accomplished in many other ways and in many otherconfigurations. The selective opening within the connector 900 c allowsthe female end of the region 922 c to close or substantially closebefore the end 913 c of the valve member 912 c engages the opening 948 cof the male end 902 c of the connector 900 c. With one end closed andthe region 922 c expanding as the valve member 912 c continues to movetoward the male end 902 c, the increasing volume urges fluid from themale end 902 c and into the region 922 c.

FIG. 40 illustrates another embodiment of a closeable male luerconnector 900 d with a male end 902 d, a housing 906 d, a female end 904d, and a resilient member 910 d. As with the embodiment of FIGS. 38-39,this embodiment also includes an internal structure for impeding orhalting the flow of fluid between the female end 904 d and the internalcavity of the connector 900 d. On an end of the valve member 912 d, afluid chamber 963 d is positioned in fluid communication within thepassageway 916 d of the valve member 912 d. In the closed position ofthe illustrated embodiment, the fluid chamber 963 d has a hole 965 dpositioned in the region 922 d and a hole 967 d positioned in thepassage 930 d between region 922 d and the region 928 d of the femaleend 904 d. In many circumstances, the flow of fluid is blocked ordiminished between the female end 904 d into the interior of theconnector 900 d due to the close peripheral fit between the conduit 963d and the passage 930 d. However, when the valve member 912 d isadvanced toward the female end 904 d, and the tip 969 d of the fluidchamber 963 d moves out of the passage 930 d and in the direction of thefemale end 904 d, the hole 967 d becomes exposed to the region 928 d ofthe female end 904 d. This enables fluid communication between thefemale end 904 d and the interior of the connector 900 d. When the valvemember 912 d is returned to its original closed position, the fluidchamber 963 d returns to its position within the region 922 d and thetip 969 d is positioned within the passage 930 d, once again preventingor impeding fluid flow between the female end 904 d and the interior ofthe connector 900 d. As the valve member 912 d returns to its originalclosed position, fluid flow between the female end 904 d and theinterior of the connector 900 d is generally impeded as soon as the hole967 d moves into passage 930 d, preferably before the end 913 d of thevalve member 912 d engages the opening 948 d of the male end 902 d ofthe connector 900 d. With fluid flow in the region 922 d in thedirection of the female end 904 d of the connector 900 d impeded, fluidis preferably drawn from the male end 902 d and into the expandingregion 922 d. Many other structures and configurations can be used toaccomplish the selective communication of fluid between the female end904 d and the interior of the connector 900 d.

FIG. 41 illustrates another embodiment of a closeable male luerconnector 900 e with a male end 902 e, a housing 906 e, a female end 904e, and a resilient member 910 e. As with the embodiments of FIGS. 38-40,this embodiment also includes an internal structure for impeding orhalting the flow of fluid between the female end 904 e and the internalcavity of the connector 900 e. On an end of the valve member 912 e, apoppet 963 e is positioned in fluid communication within the passageway916 e of the valve member 912 e. Poppet 963 e may include a first endengaging an outer surface 961 e of the valve member 912 e and a secondend 969 e. Alternatively, poppet 963 e may be formed integrally with thevalve member 912 e. The walls of the poppet 963 e generally rigid andgenerally do not deform or weaken. Moreover, the walls of the poppet 963e generally do not bulge or buckle under relatively high fluid pressureswithin the connector, nor do they generally permit the second end 969 eto become misaligned within the internal cavity of the connector 900 eunder most conditions. Many configurations of the poppet 963 e arepossible. For example, the walls of the poppet 963 e near the surface961 e may include holes or slits to facilitate fluid flow therethrough.The walls may be formed from legs extending from surface 961 e withseparation between the legs to facilitate fluid flow therethrough. Insome embodiments, the poppet 963 e includes 3 legs. In some embodiments,the poppet 963 e includes 4 or more legs.

In the closed position of the illustrated embodiment, the second end 969e of poppet 963 e is positioned in the passage 930 e between region 922e and the region 928 e of the female end 904 e. In many circumstances,the flow of fluid is blocked or diminished between the female end 904 einto the interior of the connector 900 e due to the close peripheral fitbetween the second end 969 e of the poppet 963 e and the passage 930 e.However, when the valve member 912 e is advanced toward the female end904 e, at least a portion of the second end 969 e of the poppet 963 emoves out of the passage 930 e and in the direction of the female end904 e, enabling fluid communication between the female end 904 e and theinterior of the connector 900 e. When the valve member 912 e is returnedto its original closed position, the poppet 963 e returns approximatelyto its original position within the region 922 e and the second end 969e is positioned within the passage 930 e, once again preventing orimpeding fluid flow between the female end 904 e and the interior of theconnector 900 e. The second end 969 e may include one or more flanges(not shown) extending in the direction of the male end 902 e of theconnector 900 e. These flanges would at least partially remain withinthe passage 930 e when the connector 900 e is in the opened position toassist maintaining the axial alignment of the poppet 963 e. As the valvemember 912 e returns to its original position, fluid flow between thefemale end 904 e and the interior of the connector 900 e is generallyimpeded as soon as the second end 969 e moves into passage 930 e,preferably before the end 913 e of the valve member 912 e engages theopening 948 e of the male end 902 e of the connector 900 e. With fluidflow in the region 922 d in the direction of the female end 904 d of theconnector 900 d impeded, fluid is preferably drawn from the male end 902d and into the expanding region 922 d. Many other structures andconfigurations can be used to accomplish the selective communication offluid between the female end 904 e and the interior of the connector 900e.

FIG. 42 illustrates another embodiment of a closeable male luerconnector 1000. As shown in the embodiment illustrated, the closeablemale luer connector 1000 can have a first end 1012 and a second end1014. The first end 1012 can comprise a male luer tip 1022 and a valvemember 1016 (shown in more detail in FIG. 47). The luer tip 1022 andvalve member 1016 can be supported by a housing 1023. The valve member1016 can be coupled to the housing 1023 by a resilient member 1018. Anend cap 1030 can be coupled to the housing 1023 near the second end 1014of the closeable male luer connector 1000. The end cap 1030 can haveexternal threads 1036. The embodiment of a closeable male luer connector1000 shown in FIG. 42 is in a closed position. In the closed position,valve member 1016 cooperates with male luer tip 1022 to impede the flowof fluid through the connector 1000.

As illustrated in FIG. 42, the housing 1023 can have a shroud 1024surrounding the luer tip 1022. The shroud 1024 can have internal threads1026. The internal threads 1026 and luer tip 1022 can form a male luerengagement that conforms to ANSI specifications for male luerconnectors. The end cap 1030 can have a receptacle shape that conformsto ANSI standards for female luer connectors and can receive a male luerconnector. The external threads 1036 can be disposed to threadedlyengage corresponding internal threads of a male luer connector.

The valve member 1016 can be at least partially enclosed by the housing1023. As shown, the housing 1023 can have at least one side opening1025, exposing at least a portion of the valve member 1016 and/orallowing at least a portion of the resilient member 1018 to pass intothe inside of the housing 1023. In some embodiments, housing 1023 candefine two side openings 1025 which can be disposed opposite each otheron the sides of the connector 1000. In some embodiments, side opening1025 can extend only part way along the housing 1023 (such as in acentral region of the housing 1023 as shown) to provide increasedstrength in the housing near the second end 1014. In the illustratedembodiment, the resilient member 1018 is coupled with the valve member1016 near the side openings of the housing 1023. The external side walls1027 of the housing can be contoured. For example, the external surfaceof the housing can include a narrower portion near the central region ofthe housing 1023, or a generally hour-glass-shaped outer surface, orlarger cross-section portion(s) near the ends. These shapes can providetactile confirmation of the proper placement of a user's fingers on theconnector 1000 during use and/or provide a more comfortable grippingsurface. In some embodiments, an outward projection or projections (notshown) can be incorporated on the resilient member 1018 to provideadditional or more effective gripping surfaces on the connector 1000.

The housing 1023 can include a luer tip 1022 near the first end 1012 ofthe connector 1000. The luer tip 1022 can have a hole 1021 at the endwhich can permit fluid to flow from within the housing 1023 out the luertip 1022. The valve member 1016 can include a valve closure end 1044.The closure end 1044 can engage the interior of the luer tip 1022 toinhibit the flow of fluid through the luer tip 1022. In someembodiments, an interference fit between the valve member 1016 and thehousing 1023 inhibits fluid from flowing out the luer tip 1022. In someembodiments, this interference fit is between the closure end 1044 andthe hole 1021. In some embodiments, the valve member 1016 can include aresilient section disposed near the first end 1012 of the housing 1023to engage the housing 1023 near the luer tip 1022 to inhibit fluid flowtherethrough.

As shown in the embodiment of the connector 1000 illustrated in FIG. 42,a valve closure face 1046 can be disposed across the luer tip 1022 whenthe connector 1000 is in the closed position. In some embodiments, valveclosure face 1046 can extend further beyond the hole 1021 outside of theluer tip 1022 when the connector 1000 is in the closed position. In someembodiments, the valve closure face 1046 is recessed within the luer tip1022. In some embodiments, the valve closure face 1046 is substantiallyflush with the end of the luer tip 1022. In some embodiments, the valveclosure face 1046 is configured to be swabbable when the connector 1000is in the first or closed position.

As shown in FIG. 43, the luer connector 1000 can be manipulated to asecond or open position. In the open position of the illustratedembodiment, the valve member 1016 is retracted from the luer tip 1022,thereby opening the hole 1021 in the tip 1022. As will be described ingreater detail below, fluid can pass from the luer receptacle at thesecond end 1014 through the interior of the connector 1000 and exit theluer tip 1022 at the first end 1012 when the connector 1000 is opened.When closed, fluid is impeded or blocked from passing through the luerconnector 1000 under normal operating conditions.

The resilient member 1018 can be constructed of a material thatelastically deforms. Accordingly, in some embodiments, the housing 1023can remain coupled to the valve member 1016 by the resilient member 1018when the luer connector 1000 is moved to the open position.

In the example shown, the change in relative positions of the housing1023 and valve member 1016 can cause at least a portion of the resilientmember 1018 to expand. Consequently, the resilient member 1018 exerts aclosing force on the housing 1023 and valve member 1016, biased towardreturning the luer connector 1000 to a closed state. The amount oftension carried by the resilient member 1018 can be adjusted by varyingin the distance the housing 1023 and valve member 1016 are separatedand/or by construction of the resilient member 1018 from a variety ofmaterials having different elastic properties. In some embodiments, theconnector 1000 is configured to be difficult enough to open to preventaccidental or unintentional opening. In some embodiments, the difficultyof opening the connector is controlled at least in part by the tensioncarried by the resilient member 1018.

FIG. 44 illustrates a cross-sectional view of a closeable male luer inthe closed position. As can be seen, the valve closure end 1044 canpress against the interior of the luer tip 1022 to inhibit fluid frompassing out the luer tip 1022. The valve member 1016 can include atleast one strut 1050. In some embodiments, strut 1050 can extend fromapproximately the middle of the valve member 1016 toward the first end1012. The connector 1000 can have two struts 1050, as illustrated, orthe luer connector 1000 can have more or fewer as desired. The struts1050 can be located around the luer tip 1022, but within the housing1023, as shown. The struts 1050 can be located within the inner diameterof the inner threads 1026, and are therefore positioned to couple withat least a portion of a female luer receptacle as it engages with theluer tip 1022.

As shown in FIG. 46, the resilient member 1018 can have a first ring1074 and at least one securing ring 1072. Although two securing rings1072 are shown, one or more can be used in different embodiments of theconnector 1000. The first ring 1074 can be disposed in an indentedgroove 1048 in the outer surface of the housing 1023 toward the firstend 1012. The elastic member 1018 can be tight enough around the housing1023 to keep the first ring 1074 in place when a force is exerted on theresilient member 1018 by a change in relative positions of the housing1023 and the valve member 1016. As will be described in more detailbelow, the securing ring or rings 1072 can be disposed around the valvemember 1016 in different patterns.

A passageway 1056 can extend through a portion of the valve member 1016near the first end 1012. The passageway 1056 can be circular incross-section, as shown in the illustrated embodiment, or the passageway1056 can have other geometric shapes. The passageway 1056 can have atleast one port 1062 near the first end 1012. In the illustratedembodiment, two ports 1062 are located on opposite side of the valvemember 1016 and are circular, though other locations and shapes can beused.

In the embodiment illustrated in FIG. 44, the connector 1000 is in aclosed position, and the relative positions of the valve member 1016 andhousing 1023 can create a chamber disposed between the passageway 1056and the luer receiver 1058. The chamber 1054 can be in fluidcommunication with the passageway 1056. The chamber 1054 can be widerthan the passageway 1056, as illustrated. In some embodiments, thechamber 1054 can have the same diameter as the passageway 1056 and, insome embodiments, the chamber 1054 can have a smaller diameter than thepassageway 1056. The chamber 1024 can also be configured with anon-circular cross-section in any other appropriate shape. The chamber1054 can be bounded on the end toward the second end 1014 of the housing1023 by the plunger 1070.

The plunger 1070 can be a portion of the end cap 1030 extending towardsvalve member 1016. The plunger 1070 can have a conduit 1094 through it.The conduit 1094 can place the chamber 1054 in fluid communication withthe luer receiver 1058. The plunger 1070 can have an outer dimensionsufficient to substantially close one end of the chamber 1054, as shown.In the illustrated embodiment, the plunger 1070 is circular to match thegeometry of the chamber 1054, but other geometric shapes can be used asappropriate.

The plunger 1070, though substantially sealing one end of the chamber1054, can have an outer dimension that does not contact the wall of thevalve member 1016 creating the chamber 1054. Accordingly, to inhibitfluid from escaping past the plunger 1070, an O-ring 1060 can bedisposed in a groove 1069 behind the plunger 1070. The O-ring 1060 cancontact the wall of the valve member 1016, as shown, inhibiting fluidfrom flowing out of the chamber 1054. In some embodiments, the plunger1070 is a portion of the end cap 1030. The end cap 1030 can be coupledwith the housing 1023 through sonic welding, an adhesive, or any othersuitable method for coupling. In the illustrated embodiment, end cap1030 is coupled to housing 1023 with sonic welds 1031. One such weld1031 has a substantially triangular shape as shown, though other shapesare also possible. Accordingly, the plunger 1070 can be considered to bein a static position relative to the housing 1023. In some embodiments,the plunger 1070 is formed integrally with the housing 1023 and the endcap 1030 is a separate piece appropriately attached to the housing 1023such as by sonic welding. In some embodiments, end cap 1030 isintegrally formed with housing 1023.

As shown in the illustrated embodiment in FIG. 44, fluid can flow in theluer receiver 1058 and pass to the conduit 1094. From the conduit 1094,fluid can pass to the chamber 1054 and from the chamber 1054 into thepassageway 1056. As shown in the illustrated embodiment, when theconnector 1000 is in the closed position, the valve closure end 1044 ofthe valve member 1016 can seal the hole in the luer tip 1022, preventingfluid from passing out the end of the luer tip 1022. Fluid generallycan, however, exit the passageway 1056 through the ports 1062 in thevalve member 1016. The fluid can reside in the interior of the luer tip1022, but can be prevented from flowing back towards the second end 1014on the outside of valve member 1016 by the sealing ring 1020.Accordingly, when the connector 1000 is in the closed position, asillustrated, there generally can be fluid communication between the luerreceiver 1058 and the interior of the luer tip 1022, without permittingfluid to exit the first end 1012 of the connector 1000.

In FIG. 45, an illustration of an embodiment of the connector 1000 in anopen position is shown. The connector 1000 can be changed to the openposition when a female luer connector (not shown) is mated with the luertip 1022 of the first end 1012 of the connector. When the female luerconnector is engaged with the first end 1012 of the connector 1000, aportion of the female luer connector can engage the inner threads 1026and can be advanced to at least partially enclose the luer tip 1022.Accordingly, when the female luer connector is engaged with the innerthreads 1026, a portion of the female connector can engage with thestruts 1050 and push the valve member 1016 towards the second end 1014of the housing. In the embodiment illustrated in FIG. 45, the valvemember 1016 is disposed towards the second end 1014, resulting in theconnector 1000 being in an open state.

In some embodiments, when the valve member 1016 is displaced toward thesecond end 1014, the valve closure end 1044 (see FIG. 44) separates fromthe luer tip 1022 including removal of the valve closure face 1046 fromthe hole 1021 in the luer tip 1022. Accordingly, fluid can pass out thehole in the luer tip 1022 from within the housing. The sealing ring 1020can still inhibit fluid from exiting the interior of the luer tip 1022towards the second end 1014 of the connector 1000. Accordingly, in theopen position, fluid can pass from the luer receiver 1058 through theconduit 1094, chamber 1054, passageway 1056, port or ports 1062 in thevalve member 1016, into the interior of the luer tip 1022, and out thehole 1021 in the end of the luer tip 1022.

As can be seen in the illustrated embodiment, when the struts aredisplaced toward the second end 1014 of the connector 1000, the valvemember 1016 is positioned closer to the end cap 1030. Accordingly, thewall portion of the valve member 1016 containing the terminus of thepassageway 1056 is positioned closer to the plunger 1070 portion of theend cap 1030. Thus, the volume of the chamber 1054 can be reduced whenthe connector 1000 is in the open position.

Correspondingly, when the connector 1000 is changing from an openposition to a closed position, the volume of the chamber 1054 increasesas the valve member 1016 shifts toward the first end 1012 of theconnector 1000. As the volume of the chamber 1054 increases, the valveclosure end 1044 of the valve member 1016 advances towards the first end1012 to seal the hole in the luer tip 1022. If no additional fluid isintroduced into the connector 1000 through the luer receiver 1058, theexisting fluid in the luer tip 1022 can be drawn back through the ports1062, through the passageway 1056 towards the chamber 1054 by the vacuumeffect created when the volume of the chamber 1054 increases. In thiscase, fluid can be inhibited from exiting the hole in the luer tip 1022as the valve closure end 1044 moves into place in the hole because thefluid can instead be drawn back to the chamber 1054. In someembodiments, fluid at or near the valve closure face 1046 is encouragedto move into the interior of the connector 1000 rather than remain onthe surface of the closure face 1046 as the valve member 1016 movestoward the first end 1012 of the housing 1023.

If, however, additional fluid is still being introduced into theconnector 1000 through the luer receiver 1058, the additional fluid canadvance to the chamber 1054 and collect there as the valve member 1016moves toward the first end 1012 to close the luer tip 1022. In thiscase, pressure from the newly-introduced fluid can be inhibited fromforcing fluid to flow out the luer tip 1022 as the valve member 1016seals the tip 1022. Accordingly, fluid flow is permitted through theconnector 1000 while a female connector is coupled with the first end1012 of the connector 1000, but inhibited while the female connector isbeing disengaged and after the female connector has been decoupled.

As described in greater detail below, it is desirable to inhibit certainmedicines from contacting the skin. Thus, the connector 1000advantageously assists in retaining fluid within the connector 1000 whenit is being decoupled from a female luer connector or other connection.Accordingly, reducing the likelihood of fluid exiting through the luertip 1022 when decoupling occurs results in a corresponding reduction inthe chance of exposure of toxic medicine to the skin of a user or apatient.

In FIG. 46, a cutaway of a connector 1000 is shown with a portion of thehousing removed. As can be seen, the resilient member 1018 can have afirst ring 1074 disposed in a groove 1048 of the housing 1023. Theresilient member can extend towards the second end 1014. The valvemember 1016 can have a plurality of outwardly-extending protrusions,embodied in the illustrated connector as upper flanges 1064, lowerflanges 1066, and notch flanges 1068. The resilient member can have twosecuring rings 1072 disposed around the valve member 1016 and held inplace by one or more of the flanges 1064, 1066, and 1068.

As shown in the illustrated embodiment, the securing rings 1072 can beconnected to the first ring 1074 by straps 1096. The straps 1096 cangenerally extend between the first end 1012 and the second end 1214,passing between the notch flanges 1068 of the valve member 1016. In someembodiments, the securing rings 1072 can be held in place by one edge ofthe notch flange 1068, and the lower flange 1066. The securing rings1072 can extend further toward the second end 1014 from the strap 1096,crossing each other as shown in the illustrated embodiment. In someembodiments, a separate strap 1096 can be used to connect the first ring1074 to each of the securing rings 1072. Separation of the securingrings 1072 by connecting them through the first ring 1074 and separatestraps 1096 may facilitate manufacture of the connector 1000,particularly when the side slots 1025 do not extend all the way to theend of the housing 1023 near the second end 1014 of the connector 1000.The portion of the securing ring 1072 farthest from the strap 1096 canbe enclosed by the lower and upper flanges 1064, 1066, securing it inplace around the valve member 1016 as shown. Accordingly, when the valvemember 1016 is moved toward the second end 1014 through engagement witha female connector as described above, the resilient member 1018 canexert a force on the valve member 1016 drawing it toward the first end1012. In the illustrated embodiment, the securing rings 1072 are shownoverlapping, though many other arrangements or structures are possible,including other arrangements of rings or configurations of the resilientmember having greater or fewer securing rings 1072 or a first ring 1074differently constructed or disposed can be used. As mentioned above, insome embodiments the securing rings 1072 are crossed over each other.When there are two rings 1072, crossing them over each other creates twocross-over points 1075. In some embodiments, the thickness of one orboth of the securing rings 1072 is reduced at the cross-over points 1075to create a substantially uniform securing ring 1072 around the valvemember 1016.

FIG. 47 illustrates an embodiment of the valve member 1016 comprisingthe valve closure face 1046 at the end of the valve closure end 1044.The ports 1062 can be located near the closure face 1046, or as far backas is practical from the face 1046, before the sealing ring 1020 (seeFIG. 46). The ports 1062 can be circular, as illustrated, or can haveother shapes. The struts 1050 are shown extending toward the first end1012 of the valve member 1016. There can be one, two, or more struts1050. In some embodiments, the connector 1000 does not include struts1050. Rather, the connector 1000 is adapted to be otherwise opened whenplaced in mating engagement with a female connector. For example, thefemale connector can include an engagement member (not shown) whichcould engage the valve closure face 1044 to open the connector 1000, ora manually actuated slider or button can be appropriately configured toopen the connector 1000.

The notch flanges 1068 can be comprised of two parallel protrusions fromthe main body of the valve member 1016, or otherwise appropriately sizedto couple with the resilient member 1018. The lower flange 1066 can beperpendicular to the notch flanges 1066, as illustrated. The lowerflange 1066 can also comprise more than one protrusion, extending alesser or greater distance from the main body of the valve member 1016as appropriate to couple with the resilient member 1018. The upperflange 1064 can be parallel to the lower flange 1066 and spaced apart atleast the height of a securing ring 1072 to engage the ring 1072 andinhibit the ring 1072 from moving under pressure to encircle a differentportion of the valve member 1016.

FIG. 48 illustrates an embodiment of the end cap 1030. The end cap 1030can have a sealing portion 1098 shaped and configured to substantiallyseal the second end 1014 of the housing 1023. The luer receiver 1058 canextend in one direction from the sealing portion 1098. The luer receiver1058 can be appropriately sized to couple with a male luer portion (notshown) conforming to ANSI standards for luer devices. The luer receiver1058 can have external threads 1036 to engage the male luer portion, asshown. In some embodiments, raised tabs or other protrusions can be usedto engage the male luer portion.

In some embodiments, the plunger 1070 is at the end of a portionextending the other direction from the sealing portion 1098. The plunger1070 can be sized and configured to substantially seal the chamber 1054within the valve member 1016. An indentation or slot 1069 between thesealing portion 1098 and the plunger 1070 can be sized and shaped toaccommodate an O-ring 1060, as illustrated and described above.

FIG. 49 illustrates an exploded view of the components of an example ofan embodiment of a connector 1000. In the illustrated embodiment, theresilient member 1018 is shown with overlapping securing rings 1072. Theend cap 1030 can be positioned toward the second end 1014 of theconnector 1000. The O-ring 1060 can be disposed around a portion of theend cap 1030, and the plunger 1070 can be positioned within the valvemember 1016, entering it from the second side 1014.

The resilient member 1018 is disposed around both the housing 1023 andthe valve member 1016, elastically coupling them together. The sealingring 1020 is disposed around the valve closure end 1044 of the valvemember 1016 and inside the housing 1023. The sealing ring 1020 can haveone or more protrusions 1019 corresponding to indentations in either thevalve member 1016 or the housing 1023 to substantially secure thesealing ring 1020 in place. In the illustrated embodiment, twoprotrusions 1019 extend out from the sealing ring 1020 to couple withthe housing 1023. More or fewer protrusions 1019 can be used or thesealing ring 1020 can be configured to secure to the valve member 1016.

In another embodiment illustrated in FIG. 50, components are generallynumbered similar to those in previous embodiments; however, a prime (′)has been added to corresponding numerals. As can be seen, theillustrated connector 1000′ has a resilient member 1018′ wherein thesecuring rings 1072′ are not overlapping, but set at a spaced interval.The straps 1096′ extend from the first ring 1074′ to the securing ring1072′, 1072′ at different distances. Accordingly, first strap 1096 a′ isshorter than second strap 1096 b′. The shorter strap 1096 a′ isconnected to the first securing ring 1072 a′, positioned closer to thefirst end 1014′ of the connector 1000′, and the first ring 1074′.Likewise, the longer strap 1096 b′ can extend from the first ring 1074′to the second securing ring 1072 b′.

The first securing ring 1072 a′ can be disposed between the notchflanges 1068′ and the lower flange 1066′. The second securing ring 1072b′, extending further toward the second end 1014′, can be disposedbetween the lower flange 1066′ and the upper flange 1068′. Theconfiguration of the resilient member 1018′ in the illustratedembodiment performs in a similar way as previous embodiments. Otherconfigurations are also possible.

As described above, some medications, including those used duringchemotherapy, can be harmful in certain forms of exposure to a patient.For example, exposure to the skin can sometimes result in a chemicalburn. Inhalation of aerosolized forms of some medications can beharmful. Thus, control over the containment of the medication is highlydesirable.

At present, some potentially harmful medications are distributed insealed vials. The medication is removed from the vial by inserting aneedle, and drawing the medication into a syringe. The needle is thenwithdrawn from the vial and the medication can be dispensed. However, byinserting the needle into the medication for drawing into the syringe,medication is disposed on the outside of the needle, which caninadvertently come in contact with the skin and cause harm.Alternatively, an injector which penetrates the vial with a withdrawalmechanism can be used. In such an injector, the medication is drawnthrough the mechanism and passed directly to a needle for injectionwithout the additional step of withdrawing the mechanism from the vial.Even if such an injector is used, there is still the possibility oflatent medication remaining on the needle used to inject the medication,or on the mechanism after the vial is decoupled.

Additionally, some medications can be distributed by attaching a needleto a syringe with the medication located therein. The engaged syringewith medication and needle is sterilized and placed into avacuum-sealable container. The container is then evacuated and sealed.This type of arrangement can result in the draw of medication outthrough the syringe when the container is evacuated. While in the sealedcontainer, the medication may aerosolize or coat the outer surface ofthe components.

Additionally, when the ambient atmospheric pressure of the treatmentlocation is different, particularly lower, than that of the internalpressure of the medication within a container, it is possible that anuncontrolled spray of medication can occur. For example, medication mayescape when a vial with a greater internal pressure than the ambientatmosphere is penetrated by a needle for drawing the medication into asyringe. Alternatively, medication may escape when the needle iswithdrawn from the vial before the vial seal completely closes.

A syringe mated with a closeable male luer can generally inhibit theflow of medication except during desired applications. For example, insome embodiments, a syringe with a closeable male luer connected willnot leak medication when packaged for shipment, even if the package isvacuum-sealed. Once the package is opened, the male luer connector canbe engaged with a female luer connector of an IV tube, for example, andthe medication dispensed only when the connection is engaged. Followingflow of the medication from the syringe through the engaged connectorsand into the IV tube, the male luer connector can be disengaged from thefemale luer connector. As described above, the male luer connector canclose on disengagement, preventing excess flow through the connector.When a closeable female luer connector, such as a Clave® connector soldby ICU Medical, San Clemente, Calif., is used, flow is inhibited fromexiting the female connector as well.

Additionally, a syringe with a closeable male luer can be engaged with aneedle as described above. Flow through the needle can thus becontrolled by proper use of the closeable male luer connector.Medication can also be disposed within a syringe with an integrallyformed, and/or permanently attached, closeable male luer. Thus, directexposure of the dangerous medications described can be essentiallylimited to the highly controlled environments where the medications areproduced and contained. Such medications can be placed in a syringe witha closeable male luer connector prior to distribution for use,minimizing the risk of inadvertent exposure of the medication during useof the medication.

FIG. 51 illustrates an embodiment of the end or end cap 1030″ with anexample of a structure for preventing the female end of the connectorfrom easily disengaging from a male luer inserted therein. This type ofstructure can have many different embodiments and configurations, suchas the illustrated retaining barb 1090. Many of the componentsillustrated in FIG. 51 are generally similar to those described above,except that a double prime (″) has been added to distinguish them.

The illustrated embodiment shows a retaining barb 1090 partiallyencircling the luer receiver 1058″ and partially extending through thereceiver 1058″. The retaining barb 1090 can comprise a wire having apartially circular shape through a portion of the wire, an angledsection 1091, a straight section 1093, and a barb point 1092. Thecircular portion of the barb 1090 can correspond to the outer diameterof the luer receiver 1058″, which can be along at least a portion of theexternal threads 1036″. The angled section 1091 can comprise atransition in the barb 1090 from a circular shape to the straightsection 1093, as shown in the illustrated embodiment. In the illustratedembodiment, the straight section 1093 passes through a portion of thesolid wall of the luer receiver 1058″, ending in the barb point 1092. Insome embodiments, luer receiver 1058″ includes an elongate structureextending from the wall of the receiver 1058″ and does not necessarilyinclude the other components of the illustrated barb 1090.

As illustrated in FIGS. 51-53, 55, in some embodiments, the barb point1092, 1092 . . . can comprise an inclined barb surface 1092 a, 1092 a′″.As illustrated most clearly in FIG. 51, in some embodiments, theinclined barb surface 1092 a can be configured to face toward the outersurface of the luer receiver 1058″. Conversely, as illustrated mostclearly in FIG. 52, in some embodiments, the inclined barb surface 1092a can be configured to face away from the outer surface of the luerreceiver 1058″. Similarly, as illustrated most clearly in FIG. 55, insome embodiments, the inclined barb surface 1092 a′″ can be configuredto face outward (i.e., away from the partially circular portion of theretaining barb 1090′″). Conversely, in some embodiments (notillustrated), the inclined barb surface 1092 a′″ can be configured toface inward (i.e., toward the partially circular portion of theretaining barb 1090′″). In some embodiments, the barb 1090 issubstantially symmetrical about its axis (e.g., it does not have a flatinclined surface), or the barb 1090 has a flat or rounded end with nopoint.

In some embodiments, the barb 1090 can continue to extend around theluer receiver 1058″ without penetrating it. In some embodiments, thebarb 1090 can extend through the inner wall of the luer receiver 1058″,and can potentially contact a male luer connector introduced into theluer receiver 1058″. Although circular metal wire is shown in theillustrated embodiment, wire having other cross-sections or othermaterials besides metal wire, such as plastic or a metal sheet, can alsobe used.

As described below, the barb point 1092 can have several shapes, eachadequate to perform the necessary retention. The barb point 1092 canextend from the outer wall of the luer receiver 1058″, or, asillustrated, the straight section 1093 can continue for a distancebefore the wire forms the barb point 1092.

A syringe 1080 is illustrated adjacent the luer receiver 1058″. Thesyringe can comprise a syringe shroud 1086 having inner syringe threads1084. The syringe shroud 1086 and threads 1084 can partially surround asyringe tip 1082, with all components generally conforming to ANSIstandards for luer connectors. The external threads 1036″ can beconfigured to engage corresponding threads 1084 on the inner surface ofthe syringe shroud 1086. The luer receiver 1058″ can be configured toaccept the syringe tip 1082, thereby creating a luer connection.

FIG. 52 illustrates a cross-sectional view of the end cap 1030″ of FIG.51 taken along the line 52-52. As shown, the barb 1090 can extend atleast partially around the luer receiver 1058″. In the illustratedembodiment, the barb 1090 is disposed adjacent the external thread1036″. The barb 1090 can partially encircle the luer receiver 1058″before extending through the receiver 1058″ with a straight section1093. The barb point 1092 can extend outwardly away from the luerreceiver 1058 and external thread 1036″. In some embodiments, the barbpoint 1092 can extend beyond the circular plane defined by the externalthreads 1036″. In some embodiments, barb 1090 forms an angle α with aline tangent to the external wall of the luer receiver 1058″. In someembodiments, angle α is in the range of approximately 5 to approximately75 degrees. In some embodiments, angle α is in the range ofapproximately 10 to approximately 35 degrees. Generally, angle α is lessthan approximately 90 degrees. In some embodiments, angle α is in therange of approximately 15 to approximately 30 degrees.

When a male luer connector, such as the syringe 1080, is coupled withthe illustrated end cap 1030″, the coupling can be initiated by twistingthe syringe 1080 and luer receiver 1058″ to engage the threaded surfaces1036″. As the engagement occurs, the barb point 1092 can be angled asshown to slide along the inside of the syringe shroud 1086, guided bythe syringe threads 1084. The barb point 1092 can be placed in atangential position, relative to the luer receiver 1058″, as shown toemphasize the accommodation of engagement. In addition, the angle of thepoint 1092 can be aligned to simulate an extension of the curvature ofthe luer receiver 1058

Once engagement is finished and the coupling is complete, a reversetwisting motion is generally used to decouple syringes from luerreceivers. However, when disengagement is attempted with the illustratedreceiver 1058″, the reverse twisting motion causes the barb point 1092to encounter at least a portion of the syringe shroud 1086, and becomeat least partially embedded therein. The barb point 1092 can be angledto intersect the syringe shroud 1086 when decoupling is attempted.

As the barb point 1092 pierces the syringe shroud 1086, it cansubstantially inhibit the continued disengagement, resulting inincreased difficulty in decoupling the syringe 1080 and the connector1000. For this reason, once a connector 1000 with the retaining barb1090 is coupled to a syringe or other medical device, it can bedifficult or impossible to decouple the connector without applyingincreased torque and/or structural damage to at least one of thedevices.

FIGS. 53 and 54 illustrate an embodiment of the retaining barb 1090having a sharp barb point 1092. As shown, the circular shape transitionsthrough the angled section 1091 to a straight section 1093 before endingin the barb point 1092. Although the straight section 1093 can be atleast partially embedded in the end cap 1030″, other configurations canbe used.

In the illustrated embodiment, the barb point 1092 can be ellipticallyshaped, and/or lack a true point. For example, the barb 1090 can have asharpened rounded edge or some other appropriate structure. Theillustrated embodiment can be formed by cutting the barb 1090 at anangle, resulting in the point 1092 shown.

FIGS. 55 and 56 illustrate another embodiment of the retaining barb1090′″, wherein the component sections are substantially similar, exceptthat a triple prime (′″) has been added. In the illustrated embodiment,a barb point face 1095 is present at the tip of the barb point 1092′″.The point face 1095 can be formed by cutting the tip of the barb point1092′″ to enhance the ability of the barb 1090 to puncture a medicaldevice during decoupling. Alternatively, the point face 1095 can beformed by making a cut similar to the one that forms the barb point 1092in FIGS. 53 and 54, except that the cut need not completely cross thediameter of the barb 1090′″ prior to intersecting the end of the wirefrom which the barb 1090′″ is formed. In some embodiments, this canproduce a flat barb point face 1095

Although the barb 1090 has been described to lock the luer connector1000 to another medical device, many other methods of making a couplingbetween medical devices difficult or impossible to reverse can also beused. For example, one or more barb point(s), bumps, clips, and/orprotrusions appropriately formed on the luer receiver 1058 or otherstructure can also be used.

Additionally, the retaining barb or other removal-impeding structure canbe used with other medical devices besides the closeable male luerconnector 1000 described above. The barb can be attached to any suitablemedical device having a portion adapted to connect to another luerconnector. Any other suitable device can be configured to includeremoval-impeding structure. For example, any of the devices disclosed inthe following U.S. patent applications and patents, or other devices inthe same or similar categories, can be configured to includeremoval-impeding structures: U.S. Pat. No. 6,428,520, issued Aug. 6,2002; U.S. Pat. No. 6,245,048, issued Jun. 12, 2001; U.S. Pat. No.6,695,817, issued Feb. 24, 2004; U.S. Pat. No. 6,758,833, issued Jul. 6,2004; and U.S. Pat. No. 6,599,273, issued Jul. 29, 2003; U.S. PatentPublication Nos. 2006/0161115, published Jul. 20, 2006 and 2006/0173420,published Aug. 3, 2006; and U.S. Provisional Patent Applicant No.60/854,524, filed Oct. 25, 2006. A removal-impeding structure can beespecially advantageous when the contents of a fluid container to whicha connector is attached can be unsanitary, harmful, and/or toxic.

FIGS. 57 and 58 illustrate another embodiment of a closeable male luerconnector 1100 wherein the end cap 1130 can comprise a structure forpreventing the female end of the connector from easily disengaging froma male luer inserted therein. The closeable male luer connector 1100illustrated in FIGS. 57 and 58 is similar to the closeable male luerconnector 1000 described above, except as described below. The end cap1130 of the closeable male luer connector 1100 defines another exampleof a locking arrangement 1136 thereon that, as will be described ingreater detail below, is configured not only to threadably engage thecorresponding internal threads of a male luer connector or othercomponent such as a syringe, but also to prevent or impede thedisengagement or unthreading of the male luer connector from thecorresponding male luer connector or other component to which thecloseable male luer connector 1100 is attached. Because the lockingarrangement 1136 can generally be used with any end cap or closeablemale luer, the following description will focus mainly on the lockingarrangement 1136 and not on the features of the closeable male luer 1100that are similar to those same features described above for closeablemale luer 1000.

The end cap 1130 can be formed by plastic injection molding or any othersuitable manufacturing process. The end cap 1130 can be formed from a20% glass-filled polycarbonate material, but can be formed from any oneor more other materials, such as polycarbonate, glass-filledpolycarbonate, other suitable rigid plastics, metals, alloys, etc., orcombination thereof. As with the end cap 1030 of the closeable male luerconnector 1000 described above, the end cap 1130 can be coupled with thehousing 1123 through sonic welding, an adhesive, or any other suitablemethod for coupling. In the embodiment illustrated in FIG. 58, the endcap 1130 can be coupled to the housing 1123 with sonic welds 1131. Onesuch weld 1131 has a substantially triangular shape as shown, thoughother shapes are also possible.

As shown in FIG. 59, in some embodiments, the end cap 1130 can be formedto define a plunger 1170. The plunger 1170 can be sized and configuredto substantially seal the chamber 1132 within the valve member 1116. Anindentation or slot 1169 between the sealing portion 1198 and theplunger 1170 can be sized and shaped to accommodate an O-ring or otherannular seating member, as illustrated in FIG. 58. Alternatively,plunger 1170 can be shaped to substantially mate with sealing portion1198 without the use of an additional annular sealing member. Theplunger 1170 can be considered to be in a static position relative tothe housing 1123. In some embodiments, the plunger 1170 can be formedintegrally with the housing 1123 and the end cap 1130 is a separatepiece appropriately attached to the housing 1123, such as by sonicwelding. In some embodiments, the end cap 1130 can be integrally formedwith the housing 1123.

Similar to the closeable male luer connector 1000 described above, thecloseable male luer connector 1100 can have a first end 1112 and asecond end 1114. The first end 1112 can comprise a male luer tip 1122and a valve member 1116. The luer tip 1122 and valve member 1116 can besupported by a housing 1123. The valve member 1116 can be coupled to thehousing 1123 by a resilient member 1118. As with the end cap 1030 of thecloseable male luer connector 1000, the end cap 1130 of the closeablemale luer connector 1100 can be coupled to the housing 1123 near thesecond end 1114 of the closeable male luer connector 1100. Theembodiment of the closeable male luer connector 1100 shown in FIG. 58 isin a closed position, whereby a valve closure end 1144 is positionedwithin the hole 1121 in the luer tip 1122, thereby sealing the hole 1121in the tip 1122. Thus, similar to the closeable male luer connector 1000described above, valve member 1116 cooperates with male luer tip 1122 toimpede the flow of fluid through the connector 1100 in the closedposition.

Further, the closeable male luer connector 1100 can be manipulated to asecond or open position in a manner similar to that of the closeablemale luer connector 1000 described above. In the open position of someembodiments, the valve member 1116 and valve closure end 1144 areretracted from the luer tip 1122, thereby opening the hole 1121 in thetip 1122. In the open position, fluid can pass from the luer receptacleat the second end 1114 through the interior of the connector 1100 andexit the luer tip 1122 at the first end 1112. As illustrated mostclearly in the cross-sectional view of FIG. 58, a passageway 1156 can bein fluid communication with a chamber 1132 that can extend through aportion of the valve member 1116. The chamber 1132 can also be in fluidcommunication with the internal space of the luer receiver 1158 viaconduit 1194. Thus, as shown in the illustrated embodiment in FIG. 58,fluid can flow in the luer receiver 1158 and pass to the conduit 1194.From the conduit 1194, fluid can pass to the chamber 1132 and from thechamber 1132 into the passageway 1156. Under normal operatingconditions, fluid is impeded or blocked from passing through the luerconnector 1100 when the luer connector 1100 is closed, as shown in FIG.58.

The end cap 1130 can have a sealing portion 1198 shaped and configuredto substantially seal the second end 1114 of the housing 1123. The luerreceiver 1158 can extend in an outward direction from the sealingportion 1198. The luer receiver 1158 can be appropriately sized tocouple with a male luer portion (not shown) conforming to ANSI standardsfor luer devices or to a syringe. The luer receiver 1158 illustratedherein can have a locking arrangement 1136 that in some embodimentsserves at least the following functions. The locking arrangement 1136can threadably engage with the corresponding internal threads of a maleluer connector or other component such as a syringe when the end cap1130 is rotated or threaded in a first direction (which can beclockwise) into the male luer connector of such a component.Additionally, the locking arrangement 1136 can substantially prevent orimpede the rotation or unthreading of the end cap 1130 or female portionof the male luer connector 1100 in a second direction relative to thecorresponding male luer portion of the mating component when a torque isapplied to the end cap 1130 (which can be in a counter-clockwisedirection) relative to the component to which the end cap 1130 and themale luer connector 1100 are attached.

In the illustrated embodiment, the locking arrangement 1136 can comprisea pair of oppositely disposed protrusions 1140 located on an outsidesurface 1142 of the end cap 1130. In some embodiments, the lockingarrangement 1136 can comprise only one protrusion 1140 located on theoutside surface 1142 of the end cap 1130. In some embodiments, thelocking arrangement 1136 can comprise three protrusions 1140 located onthe outside surface 1142 of the end cap 1130, which can be spaced apartat radial equidistant positions. The protrusions 1140 each preferablecomprise an outside surface 1146, a top surface 1148, a bottom surface1150, a minor side surface 1152, and a major side surface 1154. In someembodiments, the locking arrangement 1136 can comprise more than threelocking portions.

The protrusions 1140 can be positioned on the end cap 1130 such that theplanar bottom surface 1150 is coplanar with the planar end surface 1160of the end cap 1130. Each protrusion 1140 can be configured such thatthe outer surface 1146 defines a diameter that is approximately slightlyless than the inside surface diameter of the shroud 1183 of the maleluer connector or other component that the end cap 1130 mates with, asillustrated most clearly in FIG. 62. In the illustrated embodiment, theouter surface 1146 defines a diameter that is approximately 0.312 inch.This configuration is preferred though not required so that the outersurface 1146 does not interfere with, or impart a significant forceagainst, the inside surface of the shroud of the male luer portion ofthe component that the end cap 1130 is mating with. In some embodiments,the outer surface 1146 can be configured to provide an interference fitwith the inside surface of the shroud to, in whole or in part,substantially impede the decoupling of the end cap 1130 from the maleluer portion of the component to which it is connected.

In the illustrated configuration, for each protrusion 1140, theintersection of the bottom surface 1150 and the major side surface 1154can define a sharp first corner 1162. Similarly, the intersection of thetop surface 1148 and the major side surface 1154 can define a sharpsecond corner 1164. The projected length of the major side surface 1154can be slightly greater than the distance between adjacent, facing sidewalls of the internal thread of the mating component. In the illustratedembodiment, the projected length of the major side surface 1154 isapproximately 0.08 inch (i.e., the shortest distance between the secondcorner 1164 and the planar end surface 1160 is approximately 0.08 inch).To prevent a portion of the minor side surface 1152 from interferingwith the internal threads of the mating component, the length of theminor side surface 1152 can be less than the projected length of themajor side surface 1154 and also less than the distance betweenadjacent, facing side walls of the internal thread of the matingcomponent.

FIG. 62 is an enlarged side view of a portion of the end cap 1130 of thefemale connector component shown in FIG. 59, threadably inserted into amale connecting portion 1180 of a mating component 1182. As statedabove, the mating component 1182 can be a male luer connector or othercomponent such as a syringe. In FIG. 62, the mating component 1182 thatis illustrated is a syringe. The illustrated mating component 1182, orsyringe, has a syringe shroud 1183 having inner syringe threads 1184. Asillustrated in FIG. 62, the syringe shroud 1183 and threads 1184 canpartially surround a syringe tip 1185, with all components generallyconforming to ANSI standards for luer connectors. The luer receiver 1158can be configured to accept the syringe tip 1185, thereby creating aluer connection.

As is illustrated therein, the protrusion 1140 can be configured suchthat, when the end cap 1130 is threadably inserted into the male luerportion 1180 of the mating component 1182, the protrusion 1140 createsan interference fit with respect to the internal threads 1184 of themale luer portion 1180 of the mating component 1182 that impedes,substantially impedes, or prevents unthreading or decoupling of the endcap 1130 from the mating component 1182. However, the protrusion 1140preferably does not significantly inhibit the ability of the user tothread or tighten the end cap 1130 into the mating component 1182. Inthe illustrated embodiment, the first and second corners 1162, 1164 canexert a force on the side walls 1186 of the internal threads 1184 of themale luer portion 1180 of the mating component 1182 such that either orboth of the preferably sharp corners 1162, 1164 elastically orplastically deforms and embeds into the sides walls 1186 of the internalthreads 1184.

In some embodiments, as illustrated in FIGS. 60 and 61, the minor sidesurface 1152 of each protrusion 1140 can define a plane that is parallelto, but offset from, a horizontal plane (e.g., plane A) intersecting thecenterline axis of the end cap 1130 and the line 62-62. The major sidesurface 1154 of each protrusion 1140 can define a plane that can beinclined at an angle X relative to plane A when the end cap 1130 isoriented as shown in FIG. 60. In the illustrated embodiment, the majorside surface 1154 of each protrusion 1140 can be inclined at an angle,such as an angle that is approximately 12°, relative to a horizontalplane when the end cap 1130 is oriented as shown in FIG. 60. In someembodiments, the major side surface 1154 of each protrusion 1140 can beinclined at an angle that is between approximately 0° and approximately12°, or between approximately 12° and approximately 20°, or betweenapproximately 20° and approximately 30°, or between approximately 30°and approximately 40°, relative to a horizontal plane when the end cap1130 is oriented as shown in FIG. 60. In some embodiments (notillustrated), each of the two side surfaces 1152, 1154 can define aplane that intersects a longitudinal centerline axis of the end cap1130.

As illustrated most clearly in FIG. 60, the top surface 1148 of eachprotrusion 1140 can be inclined at an angle Y relative to a verticalplane when the end cap 1130 is oriented as shown in FIG. 60. In theillustrated embodiment, the top surface 1148 of each protrusion 1140 canbe inclined at an angle, such as an angle of approximately 24°, relativeto a vertical plane when the end cap 1130 is oriented as shown in FIG.60. In some embodiments, the top surface 1148 of each protrusion 1140can be inclined at an angle that is between approximately 10° andapproximately 24°, or between approximately 24° and approximately 40°,or between approximately 40° and approximately 60°, relative to avertical plane when the end cap 1130 is oriented as shown in FIG. 60.

While the locking arrangement 1136 was described above in particulardetail and was illustrated and described to be applied to the end cap1130 illustrated in FIGS. 57-62, the configuration of the lockingarrangement 1136 is not limited to this configuration. The lockingarrangement 1136 can be configured from any of a wide range of similarmaterials to those described herein or other materials that are known inthose skilled in the art that are suitable for such applications.Further, the geometrical configuration of the locking arrangement 1136is not confined to the specific arrangements illustrated and describedherein. For example, the protrusions 1140 can be configured to compriseonly one protrusion 1140, or can comprise a plurality of protrusions1140. Moreover, the protrusion 1140 can be formed such that the topsurface 1148 intersects directly with the bottom surface 1150 (i.e., sothat the protrusion 1140 has three sides and does not include the minorside surface 1152).

The protrusion 1140 can be of any suitable geometric configuration thatprovides an interference fit with the internal threads of the matingcomponent so as to impede, substantially impede, or prevent unthreadingor decoupling the end cap 1130 from a mating component, while notsignificantly inhibiting the ability of the user to thread or tightenthe end cap 1130 into the mating component. Or, more generally, theprotrusion 1140 can be of any suitable geometric configuration thatgenerally impedes, substantially impedes, or prevents unthreading ordisconnecting the end cap 1130 from a mating component, but does notsignificantly inhibit the ability of the user to thread or tighten theend cap 1130 into the mating component. For example, the outer surface1146 can be configured such that it provides an interference with theinside surface of the shroud of the mating component and/or such that itelastically or plastically deforms the inside surface of the shroud ofthe mating component to inhibit the decoupling of the end cap 1130 fromthe mating component. Also, the applicability of the locking arrangement1136 is not confined to the end cap 1130. Any end cap or other componenthaving external threads can be configured to comprise the lockingarrangement 1136 described herein. For example, an end of a catheter caninclude the locking arrangements described herein so as to impede,substantially impede, or prevent unthreading or decoupling of thecatheter from a luer lock component.

FIG. 63 illustrates another embodiment of a closeable male luerconnector 1200 configured to prevent or inhibit the male portion of thecoupled component from unthreading or decoupling from a closable maleluer connector 1200. Any of the components comprising the luer connector1200 can comprise any of the configurations, features, components,and/or materials of any of the other luer connectors described herein orthat are known to one of ordinary skill in the art. Additionally, any ofthe other luer connectors described above can comprise any of theconfigurations, features, and components of the luer connector 1200. Forexample, the features relating to preventing or inhibiting disconnectioncan be used with any suitable medical or other fluid connector.

FIGS. 63 and 64 are a perspective view and a side view, respectively, ofthe closeable male luer connector 1200 in a first or closed position. InFIG. 64, some of the internal features of the closable male luerconnector 1200 are shown in dashed lines. FIG. 65 is an explodedperspective view of the components of the embodiment of the closeablemale luer connector 1200 shown in FIG. 63. With reference to FIG. 63and/or FIG. 64, the closeable male luer connector 1200 can have a firstend 1212 and a second end 1214. The first end 1212 can comprise a maleluer tip 1222 and a valve member 1216 (shown in more detail in FIGS. 65and 71). The luer tip 1222 and valve member 1216 can be supported by ahousing 1223. The valve member 1216 can be coupled to the housing 1223by a resilient member 1218.

An end cap portion 1230 (sometimes referred to herein as an end cap or afemale member) can be coupled to the housing 1223 near the second end1214 of the closeable male luer connector 1200. One or more of thecomponents of the end cap portion 1230 can be integral or unitary withthe housing. With reference to FIG. 65, as will be described in greaterdetail below, in some embodiments, the end cap 1230 can comprise a firstend cap component 1232 (sometimes referred to herein as a first member)and a second end cap component 1234 (sometimes referred to herein as asecond member) that can be coupled together as described below. Withreference to FIG. 76, the second end cap component 1234 can define anouter surface 1234 a that is tapered, conical, or substantially conicalin shape. However, in some embodiments, the outside surface 1234 a canbe substantially cylindrical, ovular, a combination of conical andovular, or any other desired shape. The end cap 1230 can have externalthreads 1236. As mentioned, the embodiment of a closeable male luerconnector 1200 shown in FIGS. 63 and 64 is in a closed position. In theclosed position, valve member 1216 can cooperate with male luer tip 1222to substantially impede the flow of fluid through the connector 1200.

As illustrated in FIG. 63, the housing 1223 can have a shroud 1224surrounding the luer tip 1222. The shroud 1224 can have internal threads1226. The internal threads 1226 and luer tip 1222 can form a male luerengagement that conforms to ANSI specifications for male luerconnectors. The end cap 1230 can have a receptacle shape that conformsto ANSI standards for female luer connectors and can receive a maleconnecting component of another connector or syringe. The externalthreads 1236 can be disposed to threadedly engage corresponding internalthreads of a male connecting portion of the coupling component.

The valve member 1216 can be at least partially enclosed by the housing1223. As shown, the housing 1223 can have at least one side opening1225, exposing at least a portion of the valve member 1216 and/orallowing at least a portion of the resilient member 1218 to pass intothe inside of the housing 1223. In some embodiments, housing 1223 candefine two side openings 1225 which can be disposed opposite each otheron the sides of the connector 1200. In some embodiments, side opening1225 can extend only part way along the housing 1223 (such as in acentral region of the housing 1223 as shown) to provide increasedstrength in the housing near the second end 1214. In the illustratedembodiment, the resilient member 1218 can be coupled with the valvemember 1216 near the side openings of the housing 1223. The externalouter surface 1227 of the housing can be contoured. For example, theexternal surface of the housing can include a narrower portion near thecentral region of the housing 1223, or a generally hour-glass-shapedouter surface, or a larger cross-section portion(s) near the ends. Theseshapes can provide tactile confirmation of the proper placement of auser's fingers on the connector 1200 during use and/or provide a morecomfortable gripping surface. In some embodiments, an outward projectionor projections (not shown) can be incorporated on the resilient member1218 to provide additional or more effective gripping surfaces on theluer connector 1200.

As in other embodiments described herein, the luer tip 1222 near thefirst end 1212 of the connector 1200 can have a hole 1221 at the endwhich can permit fluid to flow from within the housing 1223 out the luertip 1222 when the valve member 1216 is in the open position (notillustrated). The valve member 1216 can include a valve closure end1244. The closure end 1244 can engage the interior of the luer tip 1222to inhibit the flow of fluid through the luer tip 1222. In someembodiments, an interference fit between the valve member 1216 and thehousing 1223 inhibits fluid from flowing out of the luer tip 1222. Insome embodiments, this interference fit is between the closure end 1244and the hole 1221. In some embodiments, the valve member 1216 caninclude a resilient section disposed near the first end 1212 of thehousing 1223 to engage the housing 1223 near the luer tip 1222 toinhibit fluid flow therethrough.

As shown in the embodiment of the connector 1200 illustrated in FIG. 63,a valve closure face 1246 can be disposed across the luer tip 1222 whenthe connector 1200 is in the closed position. In some embodiments, valveclosure face 1246 can be configured to extend further beyond the hole1221 outside of the luer tip 1222 when the connector 1200 is in theclosed position. In some embodiments, the valve closure face 1246 can berecessed within the luer tip 1222. In some embodiments, the valveclosure face 1246 can be substantially flush with the end of the luertip 1222. In some embodiments, the valve closure face 1246 is configuredto be swabbable when the connector 1200 is in the first or closedposition.

The luer connector 1200 can be manipulated to a second or open position.In the open position, the valve member 1216 can be retracted from theluer tip 1222, thereby opening the hole 1221 in the tip 1222. As will bedescribed in greater detail below, fluid can pass from the luerreceptacle at the second end 1214 through the interior of the connector1200 and exit the luer tip 1222 at the first end 1212 when the connector1200 is opened. When closed, fluid is impeded or blocked from passingthrough the luer connector 1200 under normal operating conditions.

The resilient member 1218 can be constructed of a material thatelastically deforms. Accordingly, in some embodiments, the housing 1223can remain coupled to the valve member 1216 by the resilient member 1218when the luer connector 1200 is moved to the open position. In theillustrated embodiment, the change in relative positions of the housing1223 and valve member 1216 can cause at least a portion of the resilientmember 1218 to extend. Consequently, the resilient member 1218 exerts aclosing force on the housing 1223 and valve member 1216, biased towardreturning the luer connector 1200 to a closed state. The amount oftension carried by the resilient member 1218 can be adjusted by varyingthe distance by which the housing 1223 and valve member 1216 areseparated, by increasing the thickness of the resilient member 1218,and/or by construction of the resilient member 1218 from a variety ofmaterials having different elastic properties. In some embodiments, theconnector 1200 is configured to be difficult enough to open to preventaccidental or unintentional opening. In some embodiments, the difficultyof opening the connector is controlled at least in part by the tensioncarried by the resilient member 1218. In some embodiments, the resilientmember 1218 can be configured as a spring positioned inside the housing1223 for biasing the valve member 1216 to the closed position. Movementof the connector 1200 to the open position can compress the spring andmovement of the connector 1200 to the closed position can allow thespring to expand to release some or all of the compression.

FIGS. 66-70 show the luer connector 1200 in the first or closedposition. As can be seen in these Figures, valve member 1216 cancomprise at least one strut 1250. In the illustrated embodiment, thevalve member 1216 can comprise two struts 1250. In some embodiments, thevalve member 1216 can comprise more than two struts 1250. In someembodiments, each strut 1250 can extend from approximately the middle ofthe valve member 1216 toward the first end 1212 of the luer connector1200. The struts 1250 can be located around the luer tip 1222, butwithin the housing 1223, as shown. The struts 1250 can be located withinthe inner diameter of the inner threads 1226, and can be positioned tocouple with at least a portion of a female luer receptacle as it engageswith the luer tip 1222.

With reference to FIG. 63, the resilient member 1218 can comprise atleast one ring 1274 and at least one securing ring 1272. However, inother embodiments, the resilient member 1218 can comprise more than onering 1274 or more than one securing ring 1272. The first ring 1274 canbe disposed in an indented groove 1248 in the outer surface of thehousing 1223 toward the first end 1212. The resilient member 1218 can betight enough around the housing 1223 to keep the first ring 1274 inplace when a force is exerted on the resilient member 1218 by a changein relative positions of the housing 1223 and the valve member 1216. Aswith the other embodiments of the luer connector described above, thesecuring ring or rings 1272 can be disposed around the valve member 1216in different patterns.

As most clearly illustrated in FIG. 67, a passageway 1256 can extendthrough a portion of the valve member 1216 near the first end 1212. Thepassageway 1256 can be circular in cross-section, as shown in theillustrated embodiment, or the passageway 1256 can have other geometricshapes. The passageway 1256 can have at least one port 1262 near thefirst end 1212. In the illustrated embodiment, two ports 1262 arelocated on opposite sides of the valve member 1216 and are circular,though other locations and shapes can be used.

In the embodiment illustrated in FIG. 67, the luer connector 1200 is ina closed position, and the relative positions of the valve member 1216and housing 1223 can create a chamber disposed between the passageway1256 and the luer receiver 1258. The chamber 1254 can be in fluidcommunication with the passageway 1256. The chamber 1254 can be widerthan the passageway 1256, as illustrated. In some embodiments, chamber1254 can have the same diameter as the passageway 1256. In someembodiments, chamber 1254 can have a smaller diameter as compared to thepassageway 1256. The chamber 1224 can also be configured with anon-circular cross-section in any other appropriate shape. The chamber1254 can be bounded on the end toward the second end 1214 of the housing1223 by the plunger 1270.

The plunger 1270 can be a portion of the end cap 1230 extending towardsvalve member 1216. The plunger 1270 can have a conduit 1294 through it.The conduit 1294 can place the chamber 1254 in fluid communication withthe luer receiver 1258. The plunger 1270 can have an outer dimensionsufficient to substantially close one end of the chamber 1254, as shown.In the illustrated embodiment, the plunger 1270 can be circular so as tomatch the geometry of the chamber 1254, but other geometric shapes canbe used, as appropriate.

The plunger 1270 can have an outer dimension that is comparable to theinner dimension of the wall of the valve member 1216 creating thechamber 1254, but that does not contact such wall to permit relativemovement between the components. To inhibit fluid from escaping past theplunger 1270, an O-ring 1260 can be disposed in a groove 1269 behind theplunger 1270. The O-ring 1260 can contact the wall of the valve member1216, as shown, inhibiting fluid from flowing out of the chamber 1254.In some embodiments, the plunger 1270 is a portion of the end cap 1230.The end cap 1230 can be coupled with the housing 1223 through sonicwelding, an adhesive, or any other suitable method for coupling. In theillustrated embodiment, end cap 1230 is coupled to housing 1223 withsonic welds 1231. One such weld 1231 has a substantially triangularshape as shown, though other shapes are also possible. Accordingly, theplunger 1270 can be considered to be in a static position relative tothe housing 1223. In some embodiments, the plunger 1270 is formedintegrally with the housing 1223 and the end cap 1230 is a separatepiece appropriately attached to the housing 1223 such as by sonicwelding. In some embodiments, the second end cap component 1234 can beintegrally formed with the housing 1223. However, as will be describedin greater detail below, the first end cap component 1232 can also beformed separately as compared to the second end cap component 1234 orthe housing 1223.

As shown most clearly in FIG. 67, fluid can flow into the luer receiver1258 and pass to the conduit 1294. From the conduit 1294, fluid can passto the chamber 1254 and from the chamber 1254 into the passageway 1256.As shown in the illustrated embodiment, when the connector 1200 is inthe closed position, the valve closure end 1244 of the valve member 1216can seal the hole in the luer tip 1222, preventing fluid from passingout the end of the luer tip 1222. Fluid generally can, however, exit thepassageway 1256 through the ports 1262 in the valve member 1216. Thefluid can reside in the interior of the luer tip 1222, but can beprevented from flowing back towards the second end 1214 on the outsideof valve member 1216 by the sealing ring 1220. Accordingly, when theconnector 1200 is in the closed position, as illustrated, theregenerally can be fluid communication between the luer receiver 1258 andthe interior of the luer tip 1222, without permitting fluid to exit thefirst end 1212 of the connector 1200.

The connector 1200 can be changed to the open position when a femaleluer connector (not shown) is mated with the luer tip 1222 of the firstend 1212 of the connector. When the female luer connector is engagedwith the first end 1212 of the connector 1200, a portion of the femaleluer connector can engage the inner threads 1226 and can be advanced toat least partially enclose the luer tip 1222. Accordingly, when thefemale luer connector is engaged with the inner threads 1226, a portionof the female connector can engage with the struts 1250 and push thevalve member 1216 towards the second end 1214 of the housing. Withreference to FIG. 63, the connector 1200 will be in an open positionwhen the valve member 1216 is disposed towards the second end 1214.

In some embodiments, when the valve member 1216 is displaced toward thesecond end 1214, the valve closure end 1244 (see FIG. 63) can separatefrom the luer tip 1222, withdrawing the valve closure face 1246 from thehole 1221 in the luer tip 1222. Accordingly, fluid can pass out the holein the luer tip 1222 from within the housing. The sealing ring 1220 caninhibits fluid from exiting the interior of the luer tip 1222 towardsthe second end 1214 of the connector 1200. Accordingly, in the openposition, fluid can pass from the luer receiver 1258 through the conduit1294, chamber 1254, passageway 1256, port or ports 1262 in the valvemember 1216, into the interior of the luer tip 1222, and out the hole1221 in the end of the luer tip 1222.

As can be seen in the illustrated embodiment, when the struts 1250 aredisplaced toward the second end 1214 of the connector 1200, the valvemember 1216 is can be moved or positioned closer to the end cap 1230.Accordingly, the wall portion of the valve member 1216 containing theterminus of the passageway 1256 is positioned closer to the plunger 1270portion of the end cap 1230. Thus, the volume of the chamber 1254 can bereduced when the connector 1200 is in the open position.

Correspondingly, when the connector 1200 is changing from an openposition to a closed position, the volume of the chamber 1254 increasesas the valve member 1216 shifts toward the first end 1212 of theconnector 1200. As the volume of the chamber 1254 increases, the valveclosure end 1244 of the valve member 1216 advances towards the first end1212 to seal the hole in the luer tip 1222. If no additional fluid isintroduced into the connector 1200 through the luer receiver 1258, theexisting fluid in the luer tip 1222 can be drawn back through the ports1262, through the passageway 1256 towards the chamber 1254 by the vacuumeffect created when the volume of the chamber 1254 increases. In thiscase, fluid can be inhibited from exiting the hole in the luer tip 1222as the valve closure end 1244 moves into place in the hole because thefluid can instead be drawn back to the chamber 1254. In someembodiments, fluid at or near the valve closure face 1246 is encouragedto move into the interior of the connector 1200 rather than remain onthe surface of the closure face 1246 as the valve member 1216 movestoward the first end 1212 of the housing 1223.

If, however, additional fluid is still being introduced into theconnector 1200 through the luer receiver 1258, the additional fluid canadvance to the chamber 1254 and collect there as the valve member 1216moves toward the first end 1212 to close the luer tip 1222. In thiscase, pressure from the newly-introduced fluid can be inhibited fromforcing fluid to flow out the luer tip 1222 as the valve member 1216seals the tip 1222. Accordingly, fluid flow is permitted through theconnector 1200 while a female connector is coupled with the first end1212 of the connector 1200, but inhibited while the female connector isbeing disengaged and after the female connector has been decoupled.

As described in greater detail below, it is desirable to inhibit certainmedicines from contacting the skin. Thus, the connector 1200advantageously assists in retaining fluid within the connector 1200 whenit is being decoupled from a female luer connector or other connection.Accordingly, reducing the likelihood of fluid exiting through the luertip 1222 when decoupling occurs results in a corresponding reduction inthe chance of exposure of toxic medicine to the skin of a user or apatient.

FIGS. 71, 72, and 73 are a perspective view of the valve member 1216,the resilient member 1218, and the housing 1223, respectively, of theembodiment of the closeable male luer connector 1200 shown in FIG. 63.As previously discussed, the resilient member 1218 can have a first ring1274 that is disposed in the groove 1248 of the housing 1223. Theresilient member can extend towards the second end 1214. The valvemember 1216 can have a plurality of outwardly-extending protrusions tosupport the resilient member 1218. In particular, with reference to FIG.71, the valve member 1216 can comprise four notch flanges 1268. Thesecuring ring 1272 (shown in FIG. 72) can be secured around the valvemember 1216 and held in place by the notch flanges 1268. However, theconfiguration of the valve member 1216 is not so limited. The valvemember 1216 can comprise any number of flanges in addition to oralternatively to the notch flanges 1268 to secure the resilient member1218 or the securing ring 1272 of the resilient member 1218 to the valvemember 1216. In the illustrated embodiment, the inside surfaces 1268 aof the notch flanges 1268 can provide lateral support to the bands 1296of the resilient member 1218 so as to prevent the bands 1296 fromsliding laterally relative to the valve member 1216. Additionally, theaft surfaces 1268 b of the notch flanges 1268 can prevent the securingring 1272 of the resilient member 1218 from sliding axially in thedirection of the valve closure face 1246 of the valve member 1216. Inother embodiments, the resilient member 1218 can comprise two or more,or, essentially, any number of rings or bands.

Additionally, with reference to FIG. 71, one or more of the ports 1262can be located at or near the closure face 1246, or as far back as ispractical from the face 1246, before the sealing ring 1220. When one ormore ports 1262 are located at the closure face 1246, another portopening mechanism can be employed such as a resilient seal. The ports1262 can be circular, as illustrated, or can have other shapes. Thestruts 1250 are shown extending toward the first end 1212 of the valvemember 1216. There can be one, two, or more struts 1250. In someembodiments, the connector 1200 does not include struts 1250. Rather,the connector 1200 can be adapted to be otherwise opened when placed inmating engagement with a female connector. For example, the femaleconnector can include an engagement member such as, but not limited to,a valve spike or other protrusion (not shown) which could engage thevalve closure face 1244 to open the connector 1200, or a manuallyactuated slider or button can be appropriately configured to open theconnector 1200.

With reference to FIGS. 73 and 74, the first end cap component 1232 canhave a covering portion 1292 shaped and configured to substantiallycover and, in some embodiments, generally seal a portion of the secondend 1214 of the housing 1223. The luer receiver 1258 can extend awayfrom the covering portion 1292. The luer receiver 1258 can beappropriately sized to couple with a male luer portion (see, e.g. FIG.12) conforming to ANSI standards for luer devices. The luer receiver1258 can have external threads 1236 to engage the male luer portion, asshown. In some embodiments, raised tabs or other protrusions can be usedto engage the male luer portion.

In some embodiments, the plunger 1270 is at the opposite end of aportion of the first end cap component 1232 from the covering portion1292. The plunger 1270 can be sized and configured to substantially sealthe chamber 1254 within the valve member 1216. An indentation or slot1269 between the covering portion 1292 and the plunger 1270 can be sizedand shaped to accommodate an O-ring 1260, as described above.Additionally, with reference to FIGS. 73 and 74, the first end capcomponent 1232 illustrated therein can comprise a pair of protrusions ortabs 1298 (also referred to herein as locking elements or engagingsurfaces) protruding radially outward from the outer surface 1300. Insome embodiments, the first end cap component 1232 can comprise a pairof tabs 1298 arranged so as to be diametrically opposing one another. Insome embodiments, the first end cap component 1232 can comprise only onetab 1298 protruding from the surface 1300. In some embodiments, thefirst end cap component 1232 can comprise more than two tabs 1298protruding from the surface 1300. As will be described in greater detailbelow, the tabs 1298 can engage or interlock with complementary tabs orprotrusions on the second end cap component 1234 to prevent the firstend cap component 1232 from rotating relative to the second end capcomponent 1234 when the two components are assembled together, as shownmost clearly in FIG. 64 or 69.

Additionally the first end cap component 1232 can define an annulargroove 1302 which, as will be described in greater detail below, caninteract with complementary features on the second end cap component1234 to axially restrain the movement of the first end cap component1232 with respect to the second end cap component 1234. Further, asillustrated most clearly in FIG. 74, the first end cap component 1232can also define an angled or tapered surface 1304 and a rounded surface1306 both positioned between the annular groove 1302 and the plunger1270. As will be described in greater detailed below, the angled ortapered surface 1304 and rounded surface 1306 can facilitate thecoupling or assembly of the first end cap component 1232 to the secondend cap component 1234. In some embodiments, the first end cap component1232 can comprise only an angled or tapered surface 1304 or a roundedsurface 1306. In other embodiments, the first end cap component 1232 canbe configured so as to not comprise either of those two features. Insome embodiments, the first end cap component 1232 and/or the second endcap component 1234 can comprise any suitable features, lubricants, ormaterials to facilitate the coupling of the first end cap component 1232and the second end cap component 1234, or, as will be discussed, tofacilitate the rotation of the first end cap component 1232 relative tothe second end cap component 1234.

In the illustrated embodiment, the tabs 1298 are substantiallyrectangular in cross-section. However, the geometry of the tabs 1298 isnot so limited. The tabs 1298 can define any suitable or desiredcross-sectional geometry, such as but not limited to a square, circular,or ovular geometry. In some embodiments, for example, a plurality oftabs 1298 each defining a circular cross-section can be arranged in alinear fashion along a side of the second end cap component 1234.

With reference to FIGS. 74-76, the second end cap component 1234 cancomprise an array of protrusions or tabs 1308 (also referred to hereinas locking elements or engaging surfaces) which protrude, in someembodiments, in a radially inward direction from the inside surface 1310of the second end cap component 1234, so as to create a radial array ofdepressions or channels 1309. With reference to FIG. 64, the first endcap component 1232 can be assembled with the second end cap component1234 such that each of the one or more tabs 1298 formed on the first endcap component 1232 is positioned in one or more of the depressions orchannels 1309 between each of the plurality of tabs 1308 formed on thesecond end cap component 1234. Accordingly, each of the one or more tabs1298 can be sized and configured such that the approximate width(represented by “W1” in FIG. 74) of each of the one or more tabs 1298formed on the surface 1300 of the first end cap component 1232 is lessthan the approximate width (represented by “W2” in FIG. 76) of thedepressions or channels 1309 between each of the tabs 1308 formed on thesecond end cap component 1234.

In the illustrated embodiment, the tabs 1308 are substantiallyrectangular in cross-section. However, the geometry of the tabs 1308 isnot so limited. The tabs 1308 can define any suitable or desiredcross-sectional geometry, such as but not limited to a square, circular,or ovular geometry.

Additionally, as mentioned, each of the one or more tabs 1298 on thefirst end cap component 1232 can be configured to shear or break offbefore any of the plurality of tabs 1308 on the second end cap component1234 shear or break off. Accordingly, in some embodiments, each of theone or more tabs 1298 on the first end cap component 1232 can beconfigured so that the minimum approximate amount of force or torquerequired to shear or break each tab 1298 away from the surface 1300 onthe first end cap component 1232 is less than the minimum approximateamount of force required to shear or break any of the tabs 1308 awayfrom the inside surface 1310 of the second end cap component 1234. Insome embodiments, the minimum amount of force required to shear or breakeach tab 1298 away from the surface 1300 on the first end cap component1232 can be significantly less than the minimum amount of force requiredto shear or break any of the tabs 1308 away from the inside surface 1310of the second end cap component 1234.

In some embodiments, the tabs or protrusions that are configured toshear or break off can be formed on the second end cap component 1234instead of being formed on the first end cap component 1232, asdescribed above. In other words, in some embodiments, one or more tabsformed on the second end cap component 1234 can be sized and/orconfigured the same as any of the tabs 1298 described above, and one ormore tabs formed on the first end cap component 1232 can be sized and/orconfigured the same as any of the tabs 1308 described above such thatthe tabs formed on the second end cap component 1234 shear or break offbefore any of the tabs formed on the first end cap component 1232. Inshort, the configurations of the tabs 1298 and tabs 1308 described abovecan be reversed. In general, other complementary engaging surfaces maybe employed. In the illustrated embodiments, each of the componentsincludes radially projecting tabs. In some embodiments, one or the otherof the components may include appropriately sized slots foraccommodating a radially projecting tab.

In some embodiments, the approximate minimum amount of force required toshear or break each tab 1298 away from the surface 1300 on the first endcap component 1232 can be less than approximately one-third of theapproximate minimum amount of force required to shear or break each ofthe tabs 1308 away from the inside surface 1310 of the second end capcomponent 1234. In some embodiments, the approximate minimum amount offorce required to shear or break each tab 1298 away from the surface1300 on the first end cap component 1232 can be between approximatelyone-third and one-half of the minimum approximate amount of forcerequired to shear or break any of the tabs 1308 away from the insidesurface 1310 of the second end cap component 1234.

In the illustrated embodiment, where two tabs 1298 are formed on thesurface 1300, the amount of torque required to shear or break both ofthe two tabs 1298 away from the surface 1300 on the first end capcomponent 1232 can be approximately 4 in-lb or more. In someembodiments, the amount of torque required to shear or break both of thetwo tabs 1298 away from the surface 1300 on the first end cap component1232 can be approximately 3 in-lb or more. In some embodiments, theamount of torque required to shear or break both of the two tabs 1298away from the surface 1300 on the first end cap component 1232 can beapproximately 5 in-lb or more.

With reference to FIG. 74, the cross-sectional area of each of the tabs1298 can be based on the approximate length (represented by “L1” in FIG.74) and approximate width (represented by “W1” in FIG. 74) of each ofthe one or more tabs 1298 at the surface 1300 of the first end capcomponent 1232. The tab 1298 can be used to define a band around thesurface 1300 calculated by multiplying the length L1 of the tab 1298 bythe circumference of the surface 1300. In some embodiments, as in theillustrated embodiment, where each of the one or more tabs 1298 isconfigured to shear away from the surface 1300 of the first end capcomponent 1232 when the desired level of torque is reached, theaggregate cross-sectional area of the tab(s) 1298 can be substantiallysmaller than the band around the surface 1300.

In some embodiments, the ratio of the aggregate cross-sectional area ofall of the one or more tabs 1298 to the value of the outside diameter(represented by “D1” in FIG. 74) of the surface 1300 of the first endcap component 1232 upon which each of the one or more tabs 1298 can beformed or attached can be approximately 1 to 46 or higher. Thecross-sectional area of each of the tabs 1298 can be any suitable valuethat results in each of the one or more tabs 1298 shearing away from thesurface 1300 when the desired level of torque is reached. For example,in some embodiments, the ratio can be between approximately 1 to 60 andapproximately 1 to 30. In some embodiments, the ratio can be betweenapproximately 1 to 50 and approximately 1 to 40.

In some embodiments, as in the illustrated embodiment, where each of theone or more tabs 1298 is configured to shear away from the surface 1300of the first end cap component 1232 when the desired level of torque isreached, the width W1 of each of the one or more tabs 1298 can besubstantially smaller than the outside diameter D1 of the surface 1300of the first end cap component 1232 upon which each of the one or moretabs 1298 can be formed or attached. The width W1 of each of the tabs1298 can be any suitable value that results in each of the one or moretabs 1298 shearing away from the surface 1300 when the desired level oftorque is reached. For example, the one or more tabs 1298 can becomparable in size or smaller than the diameter of the fluid opening inplunger 1270 and/or the luer receiver 1258. In some embodiments, theratio of the aggregate width of the tabs 1298 to the outside diameter D1can be approximately 1 to 15 or higher. In some embodiments, the ratiocan be between approximately 1 to 25 and approximately 1 to 10. In someembodiments, the ratio can be between approximately 1 to 16 andapproximately 1 to 13. In some embodiments, multiple tabs 1298 can beused wherein the widths W1 of each tab are different, but the aggregatewidths are calculated to reach the desired level of torque to shear thetabs off.

Similarly, in some embodiments, as in the illustrated embodiment, whereeach of the one or more tabs 1298 is configured to shear away from thesurface 1300 of the first end cap component 1232 when the desired levelof torque is reached, the length L1 of each of the one or more tabs 1298can be substantially smaller than the outside diameter D1 of the surface1300 of the first end cap component 1232 upon which each of the one ormore tabs 1298 can be formed or attached. The length L1 of each of thetabs 1298 can be any suitable value that results in each of the one ormore tabs 1298 shearing away from the surface 1300 when the desiredlevel of torque is reached. In some embodiments, the ratio of theaggregate length of the tabs 1298 to the outside diameter D1 can beapproximately 1 to 4 or higher. In some embodiments, the ratio can bebetween approximately 1 to 10 and approximately 1 to 2. In someembodiments, the ratio can be between approximately 1 to 5 andapproximately 1 to 3. In some embodiments, multiple tabs 1298 can beused wherein the widths W1 of each tab are different, but the aggregatewidths are calculated to reach the desired level of torque to shear thetabs off.

In some embodiments, one or more tabs 1298 can be configured such thatthe approximate width W1 of each of the one or more tabs 1298 can besignificantly less than the approximate width (represented by “W3” inFIG. 76) of one or more of the plurality of tabs 1308 formed on theinside surface 1310 of the second end cap component 1234 to ensure thatthe one or more tabs 1298 shear or break before any of the tabs 1308.Accordingly, in some embodiments, the approximate width W1 of each ofthe one or more tabs 1298 can be between approximately one-third or lessand approximately one-half or less of the approximate width W3 of eachof the plurality of tabs 1308. Moreover, in some embodiments, there aremany more tabs 1308 on the second end cap component 1234 than tabs 1298on the first end cap component 1232, thereby requiring greater torque toshear off the greater number of tabs 1308 on the second end capcomponent 1234.

In some embodiments, the material selected to form each of the one ormore tabs 1298 can be the same as or different as compared to thematerial selected to form each of the one or more tabs 1308. Thestrength of the material chosen to form the tabs 1298, 1308 can affectthe amount of torque required to shear the tabs 1298, 1308. Accordingly,in some embodiments, the tab 1298, 1308 that is desired to be shearedcan be formed from a weaker, softer, or lower durometer material ascompared to the material used to form the tab 1298, 1308 that is desiredto remain intact. For example, in the illustrated embodiment, it isdesired that the tab 1298 be sheared away from the surface 1300 on thefirst end cap component 1232 when the desired level of torque betweenthe first end cap component 1232 and the second end cap component 1234is achieved. Thus, in the illustrated embodiment, the tab 1298 can beformed from the weaker material as compared to the material used to formeach of the tabs 1308. However, because the cross-sectional area of thetabs 1298, 1308 can also affect the amount of torque required to shearthe tabs 1298, 1308, the material selected to form each of the tabs1298, 1308 can be the same.

In some embodiments, as in the illustrated embodiment, as mentioned,ensuring that the one or more tabs 1298 shear or break before any of thetabs 1308 can be achieved by also configuring each of the one or moretabs 1298 such that the approximate cross-sectional area of each of theone or more tabs 1298 is less than the cross-sectional area of each ofthe tabs 1308 that is adjacent to and, hence, will contact each of theone or more tabs 1298. With reference to FIG. 74, the cross-sectionalarea of each of the tabs 1298 is based on the length (represented by“L1” in FIG. 74) and width (represented by “W1” in FIG. 74) of each ofthe one or more tabs 1298. Similarly, width reference to FIGS. 76 and77, the cross-sectional area of each of the tabs 1308 is based on thelength (represented by “L2” in FIG. 77) and width (represented by “W3”in FIG. 76) of each of the one or more tabs 1308.

In some embodiments, without consideration of material differences,where the one or more tabs 1298 are designed to shear before any of thetabs 1308, cross-sectional area of each of the one or more tabs 1298 canbe substantially smaller than the cross-section of each of the one ormore tabs 1308. The ratio of the cross-sectional area of each of the oneor more tabs 1298 relative to the cross-sectional area of each of theone or more tabs 1308 can be significantly less than one. For example,in some embodiments, as in the illustrated embodiment, the ratio can beapproximately 1 to 14 or higher. In some embodiments, the ratio can bebetween approximately 1 to 25 and approximately 1 to 10. In someembodiments, the ratio can be between approximately 1 to 16 and 1 to 12.

Further, in some embodiments, as in the illustrated embodiment, theapproximate length (represented by “L1” in FIG. 74) of each of the oneor more tabs 1298 is significantly less than the approximate length(represented by “L2” in FIG. 77) of each of the plurality of tabs 1308formed on the inside surface 1310 of the second end cap component 1234.Accordingly, in some embodiments, the approximate length L1 of each ofthe one or more tabs 1298 can be between approximately one-third or lessand approximately two-thirds of the approximate length L2 of each of theplurality of tabs 1308.

In some embodiments, the second end cap component 1234 can definedepressions or channels into which each of the one or more tabs 1298formed on the first end cap component 1232 can be inserted when thefirst end cap component 1232 is coupled to the second end cap component1234. In some embodiments, the number of depressions or channels formedon the second end cap component 1234 can be equal to the number of tabs1298 formed on the first end cap component 1232. In some embodiments,the number of depressions or channels formed on the second end capcomponent 1234 can be greater than the number of tabs 1298 formed on thefirst end cap component 1232.

FIG. 78A is a side view of an exemplifying coupled component 1312,showing the male connecting component of the coupled component 1312partially threadedly engaged with the first end cap component 1232 ofthe closeable male luer connector 1200. FIG. 78A illustrates the end cap1230 before the one or more tabs 1298 protruding radially outwardly fromthe surface 1300 have been broken off. In FIG. 78A, the exemplifyingcoupled component 1312 is a syringe. However, the coupled component 1312can be any suitable connector or medical instrument having a maleconnecting component. As illustrated therein, the coupled component 1312is only partially threadedly engaged with the first end cap component1232 such that the torque that is exerted on the first end cap component1232 from threading the coupled component 1312 onto the first end capcomponent 1232 is less than the minimum threshold torque that isrequired to shear or break off each of the tabs 1298 from the first endcap component 1232. Thus, until the minimum threshold torque required toshear or break off each of the tabs 1298 is reached, the first end capcomponent 1232 can be rotationally fixed to the second end cap component1234 by the abutment of each of the one or more tabs 1298 formed on thefirst end cap component 1232 against one or more of the plurality oftabs 1308 formed on the second end cap component 1234.

When the coupled component 1312 is substantially fully threadedlyengaged with the first end cap component 1232, further twisting of thecoupled component 1312 will ultimately exert a torque on the first endcap component 1232 that will exceed the minimum threshold torquerequired to break off the tabs 1298 from the first end cap component1232. In some embodiments, the minimum threshold torque required tobreak off the tabs 1298 is approximately 4 in-lb of torque. Once thetabs 1298 have broken away from the first end cap component 1232, thefirst end cap component 1232 is then able to rotate substantially freelywithin the second end cap component 1234. However, the first end capcomponent 1232 can still be retained in the housing by the abutment ofthe side surface 1302 b against the side surface 1314 b of the annularprotrusion 1314. Also, the o-ring 1260 can prevent fluid exchange notwithstanding the ability of the first end cap component 1232 to rotate.In this way, the connector 1200 is prevented or inhibited from easilydisconnecting from the coupled component 1312 because the torque neededfor such disconnection would merely spin the first end cap component1232 relative to the housing 1223 and/or the second end cap component1234. Moreover, in some embodiments, there can be only a small amount of(or no) exposed outside surface area on the first end cap component 1232for contact by the fingers of a user after the coupled component 1312 isattached, thereby making it difficult to apply opposing torque to thefirst end cap component 1232 and coupled component 1312 to enabledisconnection. This can effectively “fuse” these two componentstogether.

The use of tabs configured to be sheared off is not required. Many otherstructures and configurations can be used to allow threadable connectionbetween the end of the housing and the coupled component 1312 in a firststage and then to allow rotation in a second stage to prevent or inhibitdisconnection.

FIG. 78B is a side view of the coupled component 1312, showing the maleconnecting component of the coupled component 1312 substantially fullythreadedly engaged with the first end cap component 1232 of the maleluer connector 1200. FIG. 78B illustrates the first end cap component1232 after the one or more tabs 1298′ have been broken off from theforce exerted on each of the one or more tabs 1298 by one or more of theplurality of tabs 1308 formed on the inside surface 1310 of the secondend cap component 1234 in reaction to the twisting force transferred tothe first end cap component 1232 from the substantially fully threadedlyengaged coupled component 1312. At this point, with each tab 1298′broken away from the outside surface 1300 of the first end cap component1232, the first end cap component 1232 will be able to rotatesubstantially freely within the second end cap component 1234. Anytwisting motion applied to the coupled member 1312 in either rotationaldirection relative to the housing 1223 in this arrangement will causethe first end cap component 1232 to rotate in unison with the coupledmember 1312. The coupled member 1312 is thereby prevented fromunthreading or otherwise becoming disengaged from the first end capcomponent 1232. Thus, in this manner, the luer connector 1200 isconfigured such that it cannot be removed or disengaged from the coupledmember 1312 after the luer connector 1200 and the coupled member 1312have been substantially fully coupled together.

After the one or more tabs 1298′ have been sheared or broken away fromthe first end cap component 1232, the covering portion 1292 of the firstend cap component 1232 can prevent each of the broken tabs 1298′ fromfalling out of the luer connector 1200, as shown most clearly in FIG.78B. Additionally, as illustrated most clearly in FIG. 68, the secondend cap component 1234 can be configured to prevent the broken tab 1298′from moving into the interior space of the housing 1223. In particular,the second end cap component 1234 can be configured to define an annularprotrusion 1314 that can prevent the broken tab or tabs 1298′ frommoving into the interior space of the housing 1223.

FIG. 78C is a side view of an exemplifying coupled component 1312substantially fully threadedly engaged with another embodiment of acloseable male luer connector 1200′. In some embodiments, the closeablemale luer connector 1200′ can be identical to the closable male luerconnector 1200 described above, except for as follows. In someembodiments, the second end cap component 1234′ can be configured todefine an annular space 1238′ adjacent to the tabs 1308′. The annularspace 1238′ can be sized and configured such that, when the one or moretabs 1298′ have broken away from the first end cap component 1232′, theone or more tabs 1298′ can fall into and become contained within theannular space 1238′.

In some embodiments, the first end cap component 1232 can be coupled tothe second end cap component 1234 and, hence, coupled to the luerconnector 1200, as described below. After the second end cap component1234 has been attached to the housing 1223 following any of the methodsdescribed herein or any other suitable methods, the first end capcomponent 1232 can then be co-axially aligned with the second end capcomponent 1234 and also rotationally aligned so that the each of the oneor more tabs 1298 on the first end cap component 1232 is approximatelyaligned with the one or more spaces between the tabs 1308 formed on thesecond end cap component 1234. Once the first end cap component 1232 isapproximately axially and rotationally aligned, the first end capcomponent 1232 can be inserted into the second end cap component 1234 bypushing the first end cap component 1232 against the second end capcomponent 1234, while maintaining the approximate axial and rotationalalignment described above. With reference to FIGS. 68, 74, and 77, thefirst end cap component 1232 can be pushed into the inner end until thefirst end cap component 1232 is positioned relative to the second endcap component 1234 such that the annular protrusion 1314 formed on thesecond end cap component 1234 is radially adjacent to (i.e., axiallyaligned with) the annular groove 1302 formed on the first end capcomponent 1232. In particular, in this position, the opposing sidessurfaces 1314 a and 1314 b of the annular protrusion 1314 formed in thesecond end cap component 1234 can be positioned between the optionallyopposing side surfaces 1302 a and 1302 b of the annular groove 1302formed in the second end cap component 1234.

As shown most clearly in FIG. 68, in some embodiments, the first end capcomponent 1232 and the second end cap component 1234 can be formed suchthat there will be a small gap between the generally cylindrical surface1314 c of the annular groove 1314 and the generally cylindrical surface1302 c of the annular groove 1302. This configuration can facilitaterotation of the first end cap component 1232 within the second end capcomponent 1234, i.e., without friction between the two optionallycylindrical surfaces 1302 c and 1314 c, when the one or more tabs 1298have been sheared or broken off.

Additionally, with reference to FIG. 68, the first end cap component1232 and the second end cap component 1234 can be sized and configuredsuch that the side surface 1302 b of the annular groove 1302 can overlapthe side surface 1314 b of the annular protrusion 1314 by an amount thatis sufficient to prevent the first end cap component 1232 frominadvertently being pulled out of the second end cap component 1234.Additionally, the first end cap component 1232 and the second end capcomponent 1234 can be sized and configured such that, as describedabove, the first end cap component 1232 can be inserted into the secondend cap component 1234 by axially aligning and pushing the first end capcomponent 1232 into the second end cap component 1234. Accordingly, ifthe side surface 1302 b of the annular groove 1302 overlaps the sidesurface 1314 b of the annular protrusion 1314 by too great of adistance, then it can be difficult in some configurations to couple thefirst end cap component 1232 with the second end cap component 1234 asdescribed above.

To facilitate the insertion of the first end cap component 1232 into thesecond end cap component 1234, the first end cap component 1232 can beconfigured to have an angled or tapered annular surface 1304 and/or arounded annular surface 1306 forward of the annular groove 1302, asshown most clearly in FIG. 74. Similarly, the second end cap component1234 can be configured to have an angled or tapered annular surface1316, to help align and essentially squeeze the first end cap component1232 into the second end cap component 1234, as shown most clearly inFIG. 77.

Further, as shown in the illustrated embodiments, the one or more tabs1298 and the plurality of tabs 1308 can comprise features and/or areconfigured to facilitate the insertion of the first end cap component1232 into the second end cap component 1234. For example, in someembodiments, as illustrated most clearly in FIG. 74, each of the tabs1298 can define angled or tapered front surfaces 1298 a to help guideeach of the tabs 1298 into the space between the tabs 1308 formed on thesecond end cap component 1234. Similarly, in some embodiments, asillustrated most clearly in FIGS. 75 and 77, the tabs 1308 on the secondend cap component 1234 can define angled or tapered surfaces 1308 a tohelp guide each of the tabs 1298 into the space between each of the tabs1308. Additionally, in some embodiments, each of the tabs 1308 candefine an angled or tapered forward edge 1308 b to at least assist inaxially aligning the first end cap component 1232 with the second endcap component 1234.

Any of the substantially rigid or semi-rigid components comprising theluer connecter 1200, including but not limited to the first end capcomponent 1232 and the second end cap component 1234, can comprisepolycarbonate plastic, glass-filled polycarbonates, any other suitablewater-impermeable materials, or any combinations thereof. The componentscomprising the luer connecter 1200 can also comprise a hydrophobicplastic. Other examples of materials suitable for construction of any ofthe substantially rigid or semi-rigid components comprising the luerconnecter 1200 are glass-filled GE Valox 420 or polypropylene. Dependingon the application, many other materials can also be used.

FIG. 79A is a cross-sectional view of another embodiment of a luerconnector 1400 in a closed position. FIG. 79B is a cross-sectional viewof the embodiment of the luer connector 1400 shown in FIG. 79A in anopen position. In some embodiments, the luer connector 1400 can have anyof the same features and configurations as the embodiments of the luerconnector 1000 described above, and/or any of the features orconfigurations described herein. Additionally, the luer connector 1400can comprise any of the features, components, or configurations of anyof the other luer connectors described herein.

As with the luer connector 1000 described above, the valve member 1416can include at least one strut 1450. In some embodiments, strut 1450 canextend from approximately the middle of the valve member 1416 toward thefirst end 1412. The connector 1400 can have two struts 1450, asillustrated, or the luer connector 1400 can have more or fewer asdesired. The struts 1450 can be located around the luer tip 1422, butwithin the housing 1423, as shown. The struts 1450 can be located withinthe inner diameter of the inner threads 1426, and are thereforepositioned to couple with at least a portion of a female luer receptacleas it engages with the luer tip 1422.

As shown in the embodiment illustrated in FIG. 79A, the resilient member1418 can be a helical spring supported between the end cap 1430 and anaft portion of the chamber 1420. With reference to FIG. 79A, the aftportion of the chamber 1420 can define an annular protrusion, asillustrated, or can be otherwise configured to support an end portion ofthe resilient member 1418 in an axial and radial direction so that theend portion of the resilient member 1418 adjacent thereto remainssubstantially coaxially aligned with the valve member 1416.Additionally, although not illustrated, the end cap 1430 can alsocomprise an annular protrusion or depression, or otherwise be configuredso as to provide a radial support to an end portion of the resilientmember 1418, so that the resilient member 1418 remains substantiallycoaxially aligned with the end cap 1430.

With reference to FIGS. 79A and 79B, the resilient member 1418 can beconfigured to bias the valve member 1416 to the closed position, asillustrated in FIG. 79A. When the valve member 1416 is caused to beopened, the resilient member 1418 can be axially compressed between theend cap 1430 and the aft portion of the chamber 1420, as shown mostclearly in FIG. 79B. The valve member 1416 can be caused to be openedwhen, for example, the female portion of a medical connector 92 orcomponent is threadedly engaged with the luer connector 1400 so as toaxially displace the one or more struts 1450 in the direction of thesecond end 1414 of the luer connector 1400. Therefore, in the embodimentof the luer connector 1400 illustrated in FIGS. 79A and 79B, theresilient member 1418 can provide the same or similar axial force to theresilient member 1018 described above with respect to the luer connector1000.

Additionally, because the resilient member 1418 is substantiallycompletely enclosed within the housing 1423 of the luer connector 1400,in some embodiments, the housing 1423 can be formed so as to define acontinuous annular surface (i.e., formed without any slots or otheropenings on the exterior surface, except for openings that can be formedin either of the two axial ends). In some embodiments, the annularsurface of the housing 1423 can be contoured to provide enhanced tactilefeedback and control for the user. In some embodiments, the centralportion of the housing 1423 can be formed with a smaller cross-sectionaldiameter than the first and second ends 1412, 1414.

FIG. 80A is a cross-sectional view of another embodiment of a luerconnector 1400′ in a closed position. FIG. 80B is a cross-sectional viewof the embodiment of the luer connector 1400′ shown in FIG. 80A in anopen position.

With reference to FIG. 80B, the illustrated connector 1400′ isthreadedly engaged with a closeable female luer connector 210, which canbe the same as the closable female luer connector 210 illustrated inFIG. 10 and described above. In the embodiment illustrated in FIG. 80B,the closeable female luer connector 210 can comprise an outer housing213, a void space 212, a fluid passageway 218, a fluid conduit 216 withone or more holes 215, a compressible seal element 214 with a proximalsurface 217, and a threaded engagement region 211. The closeable femaleconnector 210 can be positioned with its proximal end adjacent the firstend 1412′ of the male connector 1400′. The threaded engagement region211 of the closeable female connector 210 can conform to standard sizingfor luer connectors, such as those that meet ANSI standards. Thecompressible seal element 214 can be composed of water-impermeable,resilient material which can be moved into the housing 203 when a forceis exerted upon it. The fluid conduit 216 can be composed of a rigidmaterial, such as polycarbonate plastic, which is capable of resistingdeformation when a force sufficient to compress the seal element 214 isexerted upon the closeable female connector 210.

The fluid passageway 218 can place the fluid conduit 216 in fluidcommunication with the second end 219 of the closeable female connector210. At least one hole 215 in the fluid conduit 216 can be sealed by thecompressible seal element 214 to prevent the fluid passageway 218 frombeing in fluid communication with the void space 212 between thecompressible seal element 214 and the inner wall of the housing 213and/or with the exterior of the housing 213. The hole or holes 215 canbe appropriately sized to permit fluid to pass between the fluidpassageway 218 and the void space 212 at an appropriate flow rate. Onesuch size for the hole or holes 215 is approximately 1 mm in diameter,although irregular shapes and other sizes can be used. Holes of at leastabout 1 mm or approximately 1 mm-3 mm, or less than about 1 mm can alsobe used.

With reference to FIG. 80B, the threaded region 211 of the closeablefemale connector 210 can engage with the inner threads 1426′ of the maleconnector 1400′ to engage the connectors 1400′, 210 as illustrated. Inthe illustrated engagement, the luer tip 1422′ advances into thecloseable female connector 210 by compressing the compressible sealelement 214. As can be seen, the luer tip 1422′ contacts thecompressible seal element 214 on the proximal surface 217 of thecompressible seal element 214. The force exerted to engage theconnectors 1400′, 210 and to engage the threaded regions 1426′, 211 issufficient to compress the seal element 214 to expose the holes 215 inthe fluid conduit 216 and to open the valve member 1416′, as will bedescribed below. With the seal element 214 compressed, the fluidpassageway 218 is in fluid communication with the interior space of theluer tip 1422′.

As the luer tip 1422′ advances further into the closeable femaleconnector 210, the fluid conduit 216 contacts the end of the valvemember 1416′ adjacent to the first end 1412′ of the male connector1400′. The valve member 1416′ can be displaced toward the second end1414′ of the male connector 1400′ by the contact and continuedadvancement of the luer tip 1422′. The resilient member 1418′ exerts aclosing force in a direction towards the first end 1412′ of the maleconnector 1400′ on the valve member 1416′. As a result, the tip of thevalve member 1416′ generally maintains contact with the fluid conduit216 throughout the engagement. As the valve member 1416′ is moved in adirection towards the second end 1414′ of the male connector 1400′, theflange section 1458′ of the valve member 1416′ can separate from theinterior surface of the housing 1423′ or luer tip 1422′, therebyexposing or opening the hole 1436′. As a result, the openings 1454′ areopened to fluid communication with the closeable female connector 210.The compressed seal element 214 can inhibit fluid flow into the interiorof the closeable female connector 210 beyond the luer tip 1422′. In thisconfiguration, fluid can flow from the second end 1414′ of the luerconnector 1400′ toward the first end 1412′ of the male connector 1400′,through the openings 1454′, out the hole 1436′ in the luer tip 1422′,into the interior of the outer housing 213 of the closeable femaleconnector 210, in the holes 215 of the fluid conduit 216 and into thefluid channel 217 in the interior of the fluid conduit 216.

The connectors 1400′, 210 can be threadedly disengaged. Duringdisengagement, the force exerted by the resilient member 1418′ canreturn the connector 1400′ to its pre-engaged state by directing thevalve member 1416′ to engage the flange section 1458′ of the end of thevalve member 1416′ toward the first end 1412′ of the male connector1400′ with the internal surface of the luer tip 1422′. Likewise, theresilient material of which the compressible seal element 214 can becomposed can cause the seal element 214 to return to its closed-positionshape, and the proximal surface 217 can seal the proximal tip of thecloseable female connector 210. Any of the components of the luerconnector 1400 or 1400′ described herein can be formed from any of thesuitable materials disclosed herein, or any other materials suitable forsuch components.

FIG. 81A is a cross-sectional view of another embodiment of a luerconnector 1500 in a closed position. FIG. 81B is a cross-sectional viewof the embodiment of the luer connector 1500 shown in FIG. 81A in anopen position. In some embodiments, the luer connector 1500 can have anyof the same features and configurations as the embodiments of the luerconnector 1000 described above, and/or any of the features orconfigurations described herein. Additionally, the luer connector 1500can comprise any of the features, components, or configurations of anyof the other luer connectors described herein.

As with the luer connector 1000 described above, the valve member 1516can include at least one strut 1550. In some embodiments, strut 1550 canextend from approximately the middle of the valve member 1516 toward thefirst end 1512. The connector 1500 can have two struts 1550, asillustrated, or the luer connector 1500 can have more or fewer asdesired. The struts 1550 can be located around the luer tip 1522, butwithin the housing 1523, as shown. The struts 1550 can be located withinthe inner diameter of the inner threads 1526, and are thereforepositioned to couple with at least a portion of a female luer receptacleas it engages with the luer tip 1522.

As shown in the embodiment illustrated in FIG. 81A, the resilient member1518 can be an elastic, axially resilient material that is attached toand extends between an interior portion of the housing 1523 and anoutside surface of the chamber 1520. In some embodiments, the resilientmember 1518 can be conically shaped, the first end 1518 a being attachedto the outside surface of the chamber 1520 and a second end 1518 b beingattached to an inside surface of the housing 1523. In some embodiments,the resilient member 1518 can be formed of one or more generallyrectangular shaped tabs that extend from an inside surface of thehousing 1523 to the outside surface of the chamber 1520. In someembodiments, the resilient member 1518 can be attached to the valvemember 1516 or the housing 1523 using adhesive, an annular ring that canconstrict around the resilient member 1518 and the outside surface ofthe chamber 1520, or by any other suitable attachment means ormechanism.

With reference to FIGS. 81A and 81B, the resilient member 1518 can beconfigured to bias the valve member 1516 to the closed position, asillustrated in FIG. 81A. When the valve member 1516 is caused to beopened, the resilient member 1518 can be axially elongated, as shownmost clearly in FIG. 81B. The valve member 1516 can be caused to beopened when, for example, the female portion of a medical connector 92or component is threadedly engaged with the luer connector 1500 so as toaxially displace the one or more struts 1550 in the direction of thesecond end 1514 of the luer connector 1500. Therefore, in the embodimentof the luer connector 1500 illustrated in FIGS. 81A and 81B, theresilient member 1518 provides the same or similar axial force to thevalve member as compared to the resilient member 1018 described above inconjunction with the luer connector 1000.

Additionally, because the resilient member 1518 is substantiallycompletely enclosed within the housing 1523 of the luer connector 1500,in some embodiments, the housing 1523 can be formed so as to define acontinuous annular surface. In some embodiments, the annular surface iscontoured to provide a recessed portion to be grasped by a user.

FIG. 82A is a cross-sectional view of another embodiment of a luerconnector 1500′ in a closed position. FIG. 82B is a cross-sectional viewof the embodiment of the luer connector 1500′ shown in FIG. 82A in anopen position.

With reference to FIG. 82B, the illustrated connector 1500′ isthreadedly engaged with a closeable female luer connector 210, which canbe the same as the closable female luer connector 210 illustrated inFIG. 10 and described above. The closeable female connector 210 can bepositioned with its proximal end adjacent the first end 1512′ of themale connector 1500′. The threaded region 211 of the closeable femaleconnector 210 can engage with the inner threads 1526′ of the maleconnector 1500′ to engage the connectors 1500′, 210 as illustrated. Inthe illustrated engagement, the luer tip 1522′ can advance into thecloseable female connector 210 by compressing the compressible sealelement 215. As can be seen, the luer tip 1522′ contacts thecompressible seal element 215 on the proximal surface 217 of thecompressible seal element 215. The force exerted to engage theconnectors 1500′, 210 and to engage the threaded regions 1526′, 211 issufficient to compress the seal element 215 to expose the holes 215 inthe fluid conduit 216 and to open the valve member 1516′, as will bedescribed below. With the seal element 215 compressed, the fluidpassageway 218 can be in fluid communication with the interior space ofthe luer tip 1522′.

As the luer tip 1522′ advances further into the closeable femaleconnector 210, the fluid conduit 216 contacts the end of the valvemember 1516′ adjacent to the first end 1512′ of the male connector1500′. The valve member 1516′ can be displaced toward the second end1514′ of the male connector 1500′ by the contact and continuedadvancement of the luer tip 1522′. The resilient member 1518′ exerts aclosing force in a direction towards the first end 1512′ of the maleconnector 1500′ on the valve member 1516′. As a result, the tip of thevalve member 1516′ towards the first end 1512′ of the male connector1500′ generally maintains contact with the fluid conduit 216 throughoutthe engagement. As the valve member 1516′ is moved in a directiontowards the second end 1514′ of the male connector 1500′, the flangesection 1558′ of the valve member 1516′ can separate from the interiorsurface of the housing 1523′ or luer tip 1522′, thereby exposing oropening the hole 1536′. As a result, the openings 1554′ are opened tofluid communication with the closeable female connector 210. Thecompressed seal element 215 inhibits fluid flow into the interior of thecloseable female connector 210 beyond the luer tip 1522′. In thisconfiguration, fluid can flow from the second end 1514′ of the luerconnector 1500′ toward the first end 1512′ of the male connector 1500′,through the openings 1554′, out the hole 1536′ in the luer tip 1522′,into the interior of the outer housing 213 of the closeable femaleconnector 210, in the holes 215 of the fluid conduit 216 and into thefluid channel 217 in the interior of the fluid conduit 216.

The connectors 1500′, 210 can be threadedly disengaged. Duringdisengagement, the force exerted by the resilient member 1518′ canreturn the connector 1500′ to its pre-engaged state by directing thevalve member 1516′ to engage the flange section 1558′ of the end of thevalve member 1516′ with the internal surface of the luer tip 1522′.Likewise, the resilient material of which the compressible seal element214 can be composed can cause the seal element 214 to return to itsclosed-position shape, and the proximal surface 217 can seal theproximal tip of the closeable female connector 210. Any of thecomponents of the luer connector 1500 or 1500′ described herein can beformed from any of the suitable materials disclosed herein, or any othermaterials suitable for such components.

FIG. 83A is a cross-sectional view of another embodiment of a luerconnector 1600 in a closed position. FIG. 83B is a cross-sectional viewof the embodiment of the luer connector 1600 shown in FIG. 83A in anopen position. In some embodiments, the luer connector 1600 can have anyof the same features and configurations as the embodiments of the luerconnector 1000 described above, and/or any of the features orconfigurations described below. Additionally, the luer connector 1600can comprise any of the features, components, or configurations of anyof the other luer connectors described herein.

As with the luer connector 1000 described above, the valve member 1616can include at least one strut 1650. In some embodiments, strut 1650 canextend from the middle portion of the valve member 1616 toward the firstend 1612 of the luer connector 1600. The connector 1600 can have twostruts 1650, as illustrated, or the luer connector 1600 can have more orfewer as desired. The struts 1650 can be located around the luer tip1622, but within the housing 1623, as shown. The struts 1650 can belocated within the inner diameter of the inner threads 1626, and aretherefore positioned to couple with at least a portion of a female luerreceptacle as it engages with the luer tip 1622.

As shown in the embodiment illustrated in FIG. 83A, the resilient member1618 can be an elastic, axially resilient material having a first endportion 1618 a that is attached to the valve member 1616, and a secondend portion 1618 b that is secured to the outside of the housing 1623.In this configuration, because the first portion 1618 a of the resilientmember 1618 is located inside the housing and the second portion 1618 bis located outside the housing, the housing 1623 can define slotsthrough which the resilient member can pass. In some embodiments, theresilient member 1618 can be completely contained within the housing1623, with a first end portion being secured to the valve member 1616and a second end portion being secured to the interior surface of thehousing 1623.

In some embodiments, the resilient member 1618 can comprise one or morebands with annular rings at either end, similar to resilient member 18described above. In some embodiments, the resilient member 1618 cancomprise merely one or more generally rectangular shaped bands, having afirst end portion that is attached to the valve member 1616 and a secondend portion that is attached to the inside or outside of the housing1623. In some embodiments, the resilient member 1618 can be attached tothe valve member 1616 or the housing 1623 using adhesive, an annularring that constricts around the resilient member 1618 and the valvemember 1616, or by any other suitable attachment means or mechanism.Additionally, the valve member 1616 can define depressions, protrusions,or other features configured to axially secure a portion of theresilient member 1618 to the valve member 1616.

With reference to FIGS. 83A and 83B, the resilient member 1618 can beconfigured to bias the valve member 1616 to the closed position, asillustrated in FIG. 83A. When the valve member 1616 is caused to beopened, the resilient member 1618 can be axially elongated, as shownmost clearly in FIG. 83B. The valve member 1616 can be caused to beopened when, for example, the female portion of a medical connector orcomponent is threadedly engaged with the luer connector 1600 so as toaxially displace the one or more struts 1650 in the direction of thesecond end 1614 of the luer connector 1600. Therefore, in the embodimentof the luer connector 1600 illustrated in FIGS. 83A and 83B, theresilient member 1618 provides the same or similar axial force to thevalve member as compared to the resilient member 1018 described above inconjunction with the luer connector 1000.

In addition to the seal created by the end portion of the valve member1616 adjacent to the first end 1612 of the luer connector 1600, anadditional generally fluid-tight seal can also be created by anadditional generally planar seal 1626, which can be supported within acylindrical end portion 1630 a of the end cap 1630 as illustrated inFIG. 83A. In some embodiments, the seal 1626 can be planar and diskshaped, defining a slit 1628 through the cross-section thereof, asillustrated in FIGS. 83A and 83B. In the illustrated embodiment, theslit 1628 in the seal 1626 can be opened so as to allow fluid flowthrough the seal 1626 when the valve member is passed through the seal1626 and, hence, moved to the open position, as illustrated in FIG. 83B.The seal 1626 can be formed from silicone rubber or any other suitablematerial that can be pliable and resilient so as to be self-restoringwhen the valve member 1616 is no longer in contact with the seal 1626.The redundancy of having the additional seal 1626 (i.e., in addition toseal created between the valve member 1616 and the male luer tip 1622)may provide the benefit of further decreasing the risk any fluid leakagewhen the luer connector 1600 is in the closed position

Additionally, with reference to FIGS. 83A and 83B, the luer connector1600 can comprise a seal 1632 that can be configured to provide a sealbetween an outside surface of the chamber 1620 and the end cap 1630. Thepreferably annular seal 1632 can be configured to be sealingly attachedto the interior end portion 1630 a of the end cap 1630 and to theoutside surface of the chamber 1620, so as to generally prevent anyfluid leakage into the interior space of the housing 1623. In otherwords, the seal 1632 can be configured to generally direct the fluid ormedicament passing through the end cap 1630 into the inner passage 1634of the valve member 1616, so as to prevent leakage into the interiorspace of the housing 1623.

Additionally, the seal 1632 can be configured so that the volume ofspace V1 defined within the seal 1632 when the valve member 1616 is inthe closed position (with reference to FIG. 83A) is greater than thevolume of space V2 defined within the seal 1632 when the valve member1616 is in the open position (with reference to FIG. 83B). In thisconfiguration, as the valve member 1616 is moved toward the closedposition, the volume of space within the seal 1632 can be increased fromV1 to V2 so as to create a suction or negative pressure effect that candraw fluid from the inner passage 1634 into the volume of space (V)defined by the seal 1632. Accordingly, similar to other embodimentsdescribed herein, this configuration of the luer connector 1600 caneliminate or reduce the amount of the potentially harmful medicamentthat may otherwise leak from the luer connector 1600 as the valve member1616 is being closed.

FIG. 84A is a cross-sectional view of another embodiment of a luerconnector 1600′ in a closed position. FIG. 84B is a cross-sectional viewof the embodiment of the luer connector 1600′ shown in FIG. 84A in anopen position.

With reference to FIG. 84B, the illustrated connector 1600′ isthreadedly engaged with a closeable female luer connector 210, which canbe the same as the closable female luer connector 210 illustrated inFIG. 10 and described above. The closeable female connector 210 can bepositioned with its proximal end adjacent the first end 1612′ of themale connector 1600′. The threaded region 211 of the closeable femaleconnector 210 can engage with the inner threads 1626′ of the maleconnector 1600′ to engage the connectors 1600′, 210 as illustrated. Inthe illustrated engagement, the luer tip 1622′ can advance into thecloseable female connector 210 by compressing the compressible sealelement 215. As can be seen, the luer tip 1622′ contacts thecompressible seal element 215 on the proximal surface 217 of thecompressible seal element 215. The force exerted to engage theconnectors 1600′, 210 and to engage the threaded regions 1626′, 211 issufficient to compress the seal element 215 to expose the holes 215 inthe fluid conduit 216 and to open the valve member 1616′, as will bedescribed below. With the seal element 215 compressed, the fluidpassageway 218 is in fluid communication with the interior space of theluer tip 22.

As the luer tip 1622′ advances further into the closeable femaleconnector 210, the fluid conduit 216 contacts the end of the valvemember 1616′ adjacent to the first end 1612′ of the male connector1600′. The valve member 1616′ can be displaced toward the second end1614′ of the male connector 1600′ by the contact and continuedadvancement of the luer tip 1622′. The resilient member 1618′ can exerta closing force in a direction towards the first end 1612′ of the maleconnector 1600′ on the valve member 1616′. As a result, the tip of thevalve member 1616′ towards the first end 1612′ of the male connector1600′ generally maintains contact with the fluid conduit 216 throughoutthe engagement. As the valve member 1616′ is moved in a directiontowards the second end 1614′ of the male connector 1600′, the flangesection 1658′ of the valve member 1616′ can separate from the interiorsurface of the luer tip 1622′. As a result, the openings 1654′ areopened to fluid communication with the closeable female connector 210.The compressed seal element 215 inhibits fluid flow into the interior ofthe closeable female connector 210 beyond the luer tip 1622′. In thisconfiguration, fluid can flow from the second end 1614′ of the luerconnector 1600′ toward the first end 1612′ of the male connector 1600′,through the openings 1654′, out the hole 1630′ in the luer tip 1622′,into the interior of the outer housing 213 of the closeable femaleconnector 210, in the holes 215 of the fluid conduit 216 and into thefluid channel 217 in the interior of the fluid conduit 216.

The connectors 1600′, 210 can be threadedly disengaged. Duringdisengagement, the force exerted by the resilient member 1618′ canreturn the connector 1400′ to its pre-engaged state by directing thevalve member 1616′ to engage the flange section 1658′ of the end of thevalve member 1616′ toward the first end 1612′ of the male connector1600′ with the internal surface of the luer tip 1622′. Likewise, theresilient material of which the compressible seal element 214 can becomposed can cause the seal element 214 to return to its closed-positionshape, and the proximal surface 217 can seal the proximal tip of thecloseable female connector 210. Any of the components of the luerconnector 1600 or 1600′ described herein can be formed from any of thesuitable materials disclosed herein, or any other materials suitable forsuch components.

FIG. 85A is a cross-sectional view of another embodiment of a luerconnector 1700 in a closed position. FIG. 85B is a cross-sectional viewof the embodiment of the luer connector 1700 shown in FIG. 85A in anopen position. In some embodiments, the luer connector 1700 can have anyof the same features and configurations as the embodiments of the luerconnector 1000 described above, and/or any of the features orconfigurations described below. Additionally, the luer connector 1700can comprise any of the features, components, or configurations of anyof the other luer connectors described herein.

As with the luer connector 1000 described above, the valve member 1716can include at least one strut 1750. In some embodiments, strut 1750 canextend from approximately the middle of the valve member 1716 toward thefirst end 1712. The connector 1700 can have two struts 1750, asillustrated, or the luer connector 1700 can have more as desired. Thestruts 1750 can be located around the luer tip 1722, but within thehousing 1723, as shown. The struts 1750 can be located within the innerdiameter of the inner threads 1726, and are therefore positioned tocouple with at least a portion of a female luer receptacle as it engageswith the luer tip 1722.

As illustrated in FIG. 85A, the valve member 1716 of the luer connector1700 can also comprise a first member 1718 (also referred to herein as aresilient member) and a second member 1720. In some embodiments, thefirst member 1718 can generally be tubular in shape and formed from aflexible, substantially fluid impermeable, resilient material. In theillustrated embodiment, the first member 1718 can be resilient in boththe axial and radial directions. The first member 1718 can define anaxial opening therethrough that, when the valve member 1716 is in theopen position, permits fluid to flow through said first member 1718. Inthe illustrated embodiment, the first member 1718 can be concentricallypositioned around the second member 1720 so as to substantiallycompletely surround the second member 1720. The first member 1718 can beconfigured and positioned so that a first end portion 1718 a of thefirst member 1718 abuts against an inside end surface 1730 a of the endcap 1730. Similarly, the first member 1718 can be configured andpositioned so that a second end portion 1718 b of the first member 1718abuts against the end surface 1750 a of the one or more valve struts1750 on the opposing end of the first member 1718. Additionally, in theclosed position, the inside surface 1718 c of the first member 1718 canabut against at least a portion of the second member 1720 so that thefirst member 1718 creates a substantially fluid-tight seal with thesecond member 1720 when the valve member 1716 is in the closed position(as shown in FIG. 85A).

The second member 1720 can be substantially rigid and, as shown in FIGS.85A and 85B, can include one or more annular protrusions 1725 around theperimeter of a portion of the second member 1720, although only oneannular protrusion 1725 is shown. In the illustrated embodiment, theannular protrusion 1725 can be configured to match the geometry of theinside of the first member 1718 so as to provide a generally fluid-tightseal against the inside surface 1718 c of the first member 1718 when thevalve member 1716 is in the closed position. Additionally, the secondmember 1720 can have a first opening 1724 that is formed in the firstend portion of the second member 1720 a (i.e., the axial end portion ofthe second member 1720 that is closer to the first end 1712 of the luerconnector 1700). Similarly, the second member 1720 can have a secondopening 1726 that is formed in the second end portion of the secondmember 1720 a (i.e., the axial end portion of the second member 1720that is closer to the second end 1714 of the luer connector 1700).

With reference to FIG. 85A, the first member 1718 can be configured tobias the valve struts 1750 toward the first end 1712 of the luerconnector 1700 so that the valve struts 1750 abut against the inner wall1752. Additionally, with reference to FIG. 85A, the first member 1718can be configured so as to be biased to the closed position (i.e., sothat the inside surface 1718 c of the first member 1720 abuts againstthe annular protrusion 1725 to a sufficient degree to generally closethe fluid passageway between the second end 1714 and the first end 1712of the luer connector 1700). The amount of pressure exerted from thefirst member 1718 against the annular protrusion 1725 can be increasedby increasing the size of the perimeter of the annular protrusion 1725relative to the perimeter of the inside surface 1718 c of the firstmember 1718, thereby increasing the sealing force between the firstmember 1718 and the second member 1720 while the valve member 1716 is inthe closed position. Additionally, the level of the seal can beincreased by, for example, increasing the thickness or resilience of thematerial used to form the first member 1718 or by altering itsconfiguration.

The valve member 1717 can be caused to be opened when, for example, thefemale portion of a medical connector 92 (as shown in FIG. 85B) or acomponent is threadedly engaged with the luer connector 1700 so as toaxially displace the one or more struts 1750 in the direction of thesecond end 1714 of the luer connector 1700. The luer connector 1700 canbe configured such that, when the one or more struts 1750 are displacedtoward the second end 1714 of the luer connector 1700, the struts 1750exert an axial force on the second end portion 1718 b of the firstmember 1718 that can cause the first member 1718 to decrease in lengthand buckle or bulge outwardly at the middle portion thereof. When themiddle portion of the first member 1718 bulges outwardly, the insidesurface 1718 c can be stretched and displaced radially outward away fromannular protrusion 1725. When the inside surface 1718 c of the firstmember 1718 is no longer in contact with the annular protrusion 1725,the valve member is in an open position, as illustrated in FIG. 85B.

With reference to FIG. 85B, when the valve member 1716 is in the openposition, a fluid or medicament flowing into the second end 1714 of theluer connector 1700 can flow through the second opening 1726, into thespace between the first member 1718 and the second member 1720, aroundthe protrusion 1725, through the first opening 1724, through thepassageway 1756 and out through the end of the luer tip 1722.

Conversely, as the medical connector 92 is unthreaded or removed fromthe luer connector 1700, the axial bias from the first member 1718 cancause the first member 1718 to elongate to its pre-bulge arrangement,causing the struts 1750 to move toward the first end 1712 and, in someembodiments, to abut against the inner wall 1752. Similarly, as themedical connector 92 is unthreaded or removed from the luer connector1700, the inward radial bias from the first member 1718 can cause thefirst member 1718 to constrict and form a seal around the annularprotrusion 1725, generally preventing any further fluid from flowingthrough the valve member 1716.

In some embodiments, the second member 1720 can be formed separately ascompared to the luer tip 1722. However, in some embodiments, the secondmember 1720 can be formed integrally with the luer tip 1722.Additionally, because the first member 1718 can generally be completelyenclosed within the housing 1723 of the luer connector 1700, in someembodiments, the housing 1723 can be formed so as to define a continuousannular surface. Any of the components of the luer connector 1700described herein can be formed from any of the suitable materialsdisclosed herein, or any other materials suitable for such components.

FIG. 86A is a cross-sectional view of another embodiment of a luerconnector 1800 in a closed position. FIG. 86B is a cross-sectional viewof the embodiment of the luer connector 1800 shown in FIG. 86A in anopen position. In some embodiments, the luer connector 1800 can have anyof the same features and configurations as the embodiments of the luerconnector 1000 described above, and/or any of the features, components,or configurations of any of the other luer connectors described herein.

As illustrated in FIG. 86A, the valve member 1816 can include at leastone lever arm 1850. In particular, the luer connector 1800 illustratedin FIG. 86A comprises two opposing lever arms 1850, although the luerconnector 1800 can comprise any suitable any number of lever arms 1850.As illustrated therein, each lever arm 1850 can be pivotally mountedabout a shaft 1852 that can be supported in a fixed position relative tothe housing 1823, but that can rotate relative to the housing 1823 so asto allow the lever arm 1850 to rotate relative to the housing 1823. Insome embodiments, as in the illustrated embodiments, the lever arms 1850can extend outside of the housing 1823 through slots 1824 that can beformed in the housing 1823.

Each lever arm 1850 can be supported by the housing 1823 so that thefirst end portion 1850 a of the lever arm 1850 can abut the chamber1854, while the second end portion 1850 b can be positioned adjacent tothe luer tip 1822. In particular, in the illustrated embodiment, thelever arm 1850 can be supported by the housing 1823 so that a bottomsurface 1850 c of the first end portion 1850 a can abut the outsidesurface 1854 a of the chamber 1854. Similarly, in the illustratedembodiment, the lever arm 1850 can be supported by the housing 1823 sothat a bottom surface 1850 d of the second end portion 1850 b of eachlever arm 1850 can be positioned generally within the housing 1823 beenaround the luer tip 1822, as shown. The bottom surface 1850 d of thesecond end portion 1850 b of each lever arm 1850 can be located withinthe inner diameter of the inner threads 1826.

In this configuration, with reference to FIG. 86B, as the female portionof a medical connector 92 is threadedly engaged with the threads 1826 ofthe luer connector 1800 and advanced toward the second end 1814 of theluer connector 1800, as indicated by the arrows A1 in FIG. 86B, thedistal tip 92 a of the medical connector 92 can contact the bottomsurface 1850 d of the second end portion 1850 b of each lever arm 1850.As the medical connector 92 is advanced further toward the second end1814, the distal end to 92 a of the medical connector 92 can force thesecond end portion 1850 b of each lever arm 1850 in a radially outwarddirection, as indicated by the arrows A2 in FIG. 86B. Because each leverarm 1850 can rotate about the shaft 1852, as the second end portion 1850b of each lever arm 1850 is forced radially outward, the first endportion 1850 a of each lever arm 1850 can rotate and move radiallyinward, as indicated by arrows A3 shown in FIG. 86B.

Forcing the first end portion 1850 a of each lever arm 1850 inwardly cancause the bottom surface 1850 c to exert a radially inward force againstthe outside surface 1854 a of the chamber 1854, in the direction of thearrows A3 shown in FIG. 86B. The lever arms 1850 and the chamber 1854can be configured such that the reaction force from the first endportion 1850 a on the chamber 1854 as the first end portion 1850 a isconstricted inwardly against the chamber 1854 causes the chamber 1854and, consequently, the valve member 1816 to move axially toward thesecond end 1814 of the luer connector 1800. As the valve member 1816moves axially toward the second end 1814 of the luer connector 1800, thevalve member is caused to be opened such that fluid or medicaments canflow through the valve member 1816 and out through the opening 1856 inthe distal end of the luer tip 1822, as shown in FIG. 86B.

A resilient member 1818, which can be formed from a helical spring, canbe positioned between the end cap 1830 and the chamber 1854, asillustrated in FIGS. 86A and 86B. The aft portion of the chamber 1854can define an annular protrusion or can be otherwise configured tosupport an end portion of the resilient member 1818 in an axial andradial direction so that the end portion of the resilient member 1818adjacent thereto remains substantially coaxially aligned with the valvemember 1816. Additionally, the end cap 1830 can also comprise an annularprotrusion or depression, or otherwise be configured so as to provide aradial support to an end portion of the resilient member 1818, so thatthe resilient member 1818 remains substantially coaxially aligned withthe end cap 1813.

With reference to FIGS. 86A and 86B, the resilient member 1818 can beconfigured to bias the valve member 1816 to the closed position, asillustrated in FIG. 86A. When the valve member 1816 is caused to beopened, the resilient member 1818 can be axially compressed between theend cap 1830 and the aft portion of the chamber 1854, as shown mostclearly in FIG. 86B. The resilient member 1818 can bias the chamber 1854and the valve member 1816 toward the first end 1812 of the luerconnector 1800, so as to bias the valve member 1816 toward the closedposition. In this configuration, as the medical connector 92 is removedfrom the luer connector 1800, the resilient member 1818 can bias thevalve member 1816 toward the closed position and also can bias the leverarms 1850 to rotate about the shaft 1852 so that the first end portion1850 a rotates radially outward.

A seal 1868 between the inner surface of the chamber 1854 and a portionof the end cap 1830 can prevent fluid from leaking through the spacebetween the inner surface of the chamber 1854 and a portion of the endcap 1830. The chamber 1854 can be formed integrally with the valvemember 1816, or can be formed separately and adhered, fused, orotherwise attached to the valve member 1816. Any of the components ofthe luer connector 1800 described herein can be formed from any of thesuitable materials disclosed herein, or any other materials suitable forsuch components.

Some medications, including those used during chemotherapy, can beharmful to a patient in certain applications. For example, exposure tothe skin can sometimes result in a chemical burn. Inhalation ofaerosolized forms of some medications also can be harmful. Thus, controlover the containment of the medication is highly desirable.

Some potentially harmful medications are distributed in sealed vials.The medication is removed from the vial by inserting a needle or a vialadaptor, and drawing the medication into a syringe. If a needle is used,it is withdrawn from the vial and the medication can be dispensed.However, the needle may be withdrawn with a residue of medicationdisposed on the outside of the needle or the vial adaptor may include aresidue of medication on one or more exposed surfaces. This medicationcan inadvertently come in contact with the skin and cause harm. Or, ifan injector is used to penetrate the vial with a withdrawal mechanism,the medication can be drawn through the mechanism and passed directly toa syringe for injection without the additional step of withdrawing themechanism from the vial. However, even if such an injector is used,there is still the possibility of latent medication remaining on theneedle used to inject the medication, on the mechanism after the vial isdecoupled, or on the mechanism after the syringe is decoupled.

Any features of the embodiments shown and/or described in the Figuresthat have not been expressly described in this text, such as distances,proportions of components, etc. are also intended to form part of thisdisclosure. Additionally, although these inventions have been disclosedin the context of various embodiments, features, aspects, and examples,it will be understood by those skilled in the art that the presentinventions extend beyond the specifically disclosed embodiments to otheralternative embodiments and/or uses of the inventions and obviousmodifications and equivalents thereof. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combined with, or substituted for, one another inorder to perform varying modes of the disclosed inventions. Moreover,any component or combination of components disclosed herein can be usedin other structures of configurations of medical connectors. Thus, it isintended that the scope of the present inventions herein disclosedshould not be limited by the particular disclosed embodiments describedabove.

As used throughout this specification, the terms “first end” and “secondend” are labels of convenience that apply to a female side or a maleside of a valve, or both. The labels are used interchangeably herein. Byway of example, each of the structures of the embodiments disclosedherein for preventing or inhibiting disconnection of two medicalconnectors can be employed on either the male or female sides (or both).Any particular use of “first” or “second” with “female” or “male” shouldnot be restricted to such end.

1. A luer connector comprising: a rigid housing, a first end portioncomprising a rigid tubular male member configured to be engageable witha female connector and positioned at a first end of the housing, asecond end portion comprising a rigid tubular female member andpositioned at a second end of the housing; the female member beingconfigured to define at least a first arrangement wherein the femalemember is configured to allow a male connector to rotate substantiallyunimpeded in either a first direction or a second direction relative tothe female member, the first direction being defined as the directionthat permits the male connector to threadably engage the female member,and the second direction being defined as the direction that permits themale connector to threadably disengage the female member, and a secondarrangement wherein the female member is configured to prevent or impedethe male connector from rotating in the first direction or the seconddirection relative to the female member; and the female member beingfurther configured to change from the first arrangement to the secondarrangement when the male connector is further rotated in the firstdirection beyond a point at which the male connector is substantiallyfully engaged with the female member; wherein: the female membercomprises an inner member supported by the housing so as to besubstantially prevented from rotating relative to the housing in eitherthe first or second arrangement and an outer member configured so as tobe threadably engageable by the male connector; in the firstarrangement, the outer member is substantially prevented from rotatingrelative to the inner member and, in the second arrangement, the outermember is substantially permitted to rotate in either the firstdirection or the second direction relative to the inner member; and theouter member comprises at least one protrusion and the inner membercomprises at least one channel configured to receive the at least oneprotrusion, each protrusion being configured to break off when the maleconnector is rotated in the first direction beyond the point where themale connector is substantially fully engaged with the female member. 2.The luer connector of claim 1, wherein the outer member is supported bythe inner member.
 3. The luer connector of claim 1, wherein the luerconnector comprises at least one material selected from the groupconsisting of rigid plastic, polycarbonate, glass-filled plastic, metal,and metal alloy.
 4. The luer connector of claim 1, further comprising amale luer tip with a tapering interior surface at the first end.
 5. Theluer connector of claim 1, further comprising a valve member configuredto alter the flow of a fluid through the luer connector.
 6. The luerconnector of claim 5, wherein the valve member is rigid.
 7. The luerconnector of claim 5, wherein the valve member at least partiallyextends through the housing and comprises: a first opened end and asecond closed end; a passageway within the valve member; an outwardlyextending flange near the second end adapted to seal a hollow bore atthe second end of the housing when placed in contact with the taperinginterior surface of the housing; at least one opening near the closedend of the valve member extending outwardly from the passageway throughthe valve member; at least one strut connected to the valve member andextending towards the second end of the valve member, the at least onestrut extending substantially parallel to the central axis of the valvemember and at least partially surrounding a narrow section of the valvemember ending in the second closed end; a retaining member configured tocouple the valve member and the housing; and a sealing element disposedwithin the housing and configured to inhibit fluid communication throughthe hollow bore of the housing between the interior of the male luer tipof the housing and the first end of the housing.
 8. The luer connectorof claim 1, comprising a plurality of channels uniformly spaced about anoutside surface of the inner member.
 9. A method of using the luerconnector of claim 1, comprising: threadably engaging the female memberof the luer connector with the male connector; and rotating the maleconnector relative to the female member in the first direction beyondthe point at which the male connector is substantially fully engagedwith the female member.
 10. The method of using the luer connector ofclaim 9, further comprising confirming that the luer connector is in thesecond arrangement by rotating the male connector in the first directionrelative to the female member after rotating the male connector relativeto the female member in the first direction beyond the point at whichthe male connector is substantially fully engaged with the femalemember.
 11. A luer connector comprising: a rigid housing, a first endportion comprising a rigid tubular male member configured to beengageable with a female connector and positioned at a first end of thehousing, a second end portion comprising a rigid tubular female memberand positioned at a second end of the housing; the female member beingconfigured to define at least a first arrangement wherein the femalemember is configured to allow a male connector to rotate substantiallyunimpeded in either a first direction or a second direction relative tothe female member, the first direction being defined as the directionthat permits the male connector to threadably engage the female member,and the second direction being defined as the direction that permits themale connector to threadably disengage the female member, and a secondarrangement wherein the female member is configured to prevent or impedethe male connector from rotating in the first direction or the seconddirection relative to the female member; and the female member beingfurther configured to change from the first arrangement to the secondarrangement when the male connector is further rotated in the firstdirection beyond a point at which the male connector is substantiallyfully engaged with the female member; wherein: the female membercomprises an inner member supported by the housing so as to besubstantially prevented from rotating relative to the housing in eitherthe first or second arrangement and an outer member configured so as tobe threadably engageable by the male connector; in the firstarrangement, the outer member is substantially prevented from rotatingrelative to the inner member and, in the second arrangement, the outermember is substantially permitted to rotate in either the firstdirection or the second direction relative to the inner member; and theinner member comprises at least one protrusion and the outer membercomprises at least one channel configured to receive the at least oneprotrusion, each protrusion is configured to break off when the maleconnector is rotated in the first direction beyond the point where themale connector is substantially fully engaged with the female member.12. The luer connector of claim 11, wherein the luer connector comprisesat least one material selected from the group consisting of rigidplastic, polycarbonate, glass-filled plastic, metal, and metal alloy.13. The luer connector of claim 11, further comprising a male luer tipwith a tapering interior surface at the first end.
 14. The luerconnector of claim 11, further comprising a valve member configured toalter the flow of a fluid through the luer connector.
 15. The luerconnector of claim 14, wherein the valve member is rigid.
 16. The luerconnector of claim 14, wherein the valve member at least partiallyextends through the housing and comprises: a first opened end and asecond closed end; a passageway within the valve member; an outwardlyextending flange near the second end adapted to seal a hollow bore atthe second end of the housing when placed in contact with the taperinginterior surface of the housing; at least one opening near the closedend of the valve member extending outwardly from the passageway throughthe valve member; at least one strut connected to the valve member andextending towards the second end of the valve member, the at least onestrut extending substantially parallel to the central axis of the valvemember and at least partially surrounding a narrow section of the valvemember ending in the second closed end; a retaining member configured tocouple the valve member and the housing; and a sealing element disposedwithin the housing and configured to inhibit fluid communication throughthe hollow bore of the housing between the interior of the male luer tipof the housing and the first end of the housing.
 17. The luer connectorof claim 11, comprising a plurality of channels uniformly spaced aboutan inside surface of the outer member.
 18. A method of using the luerconnector of claim 11, comprising: threadably engaging the female memberof the luer connector with the male connector; and rotating the maleconnector relative to the female member in the first direction beyondthe point at which the male connector is substantially fully engagedwith the female member.
 19. The method of using the luer connector ofclaim 18, further comprising confirming that the luer connector is inthe second arrangement by rotating the male connector in the firstdirection relative to the female member after rotating the maleconnector relative to the female member in the first direction beyondthe point at which the male connector is substantially fully engagedwith the female member.
 20. A luer connector comprising: a rigidhousing, a first end portion comprising a rigid tubular male memberconfigured to be engageable with a female connector and positioned at afirst end of the housing, a second end portion comprising a rigidtubular female member and positioned at a second end of the housing; thefemale member being configured to define at least a first arrangementwherein the female member is configured to allow a male connector torotate substantially unimpeded in either a first direction or a seconddirection relative to the female member, the first direction beingdefined as the direction that permits the male connector to threadablyengage the female member, and the second direction being defined as thedirection that permits the male connector to threadably disengage thefemale member, and a second arrangement wherein the female member isconfigured to prevent or impede the male connector from rotating in thefirst direction or the second direction relative to the female member;and the female member being further configured to change from the firstarrangement to the second arrangement when the male connector is furtherrotated in the first direction beyond a point at which the maleconnector is substantially fully engaged with the female member;wherein: the female member comprises an inner member supported by thehousing so as to be substantially prevented from rotating relative tothe housing in either the first or second arrangement and an outermember configured so as to be threadably engageable by the maleconnector; in the first arrangement, the outer member is substantiallyprevented from rotating relative to the inner member and, in the secondarrangement, the outer member is substantially permitted to rotate ineither the first direction or the second direction relative to the innermember; and the outer member comprises at least one protrusion and theinner member comprises at least one channel configured to receive the atleast one protrusion, each protrusion is configured to break off whenapproximately 3 in-lb to approximately 5 in-lb or more of torque isapplied to the male connector relative to the luer connector.
 21. Theluer connector of claim 20, wherein each protrusion is configured tobreak off when the male connector is rotated in the first directionbeyond the point where the male connector is substantially fully engagedwith the female member.
 22. The luer connector of claim 20, wherein theluer connector comprises at least one material selected from the groupconsisting of rigid plastic, polycarbonate, glass-filled plastic, metal,and metal alloy.
 23. The luer connector of claim 20, further comprisinga male luer tip with a tapering interior surface at the first end. 24.The luer connector of claim 20, further comprising a valve memberconfigured to alter the flow of a fluid through the luer connector. 25.The luer connector of claim 24, wherein the valve member is rigid. 26.The luer connector of claim 24, wherein the valve member at leastpartially extends through the housing and comprises: a first opened endand a second closed end; a passageway within the valve member; anoutwardly extending flange near the second end adapted to seal a hollowbore at the second end of the housing when placed in contact with thetapering interior surface of the housing; at least one opening near theclosed end of the valve member extending outwardly from the passagewaythrough the valve member; at least one strut connected to the valvemember and extending towards the second end of the valve member, the atleast one strut extending substantially parallel to the central axis ofthe valve member and at least partially surrounding a narrow section ofthe valve member ending in the second closed end; a retaining memberconfigured to couple the valve member and the housing; and a sealingelement disposed within the housing and configured to inhibit fluidcommunication through the hollow bore of the housing between theinterior of the male luer tip of the housing and the first end of thehousing.
 27. The luer connector of claim 20, comprising a plurality ofchannels uniformly spaced about an inside surface of the outer member.28. A method of using the luer connector of claim 20, comprising:threadably engaging the female member of the luer connector with themale connector; and rotating the male connector relative to the femalemember in the first direction beyond the point at which the at least oneprotrusion breaks off of the outer member.
 29. The method of using theluer connector of claim 28, further comprising confirming that the luerconnector is in the second arrangement by rotating the male connector inthe first direction relative to the female member after rotating themale connector relative to the female member in the first directionbeyond the point at which the at least one protrusion breaks off of theouter member.
 30. The luer connector of claim 24, wherein eachprotrusion is configured to break off when approximately 4 in-lb or moreof torque is applied to the male connector relative to the luerconnector.
 31. A luer connector comprising: a rigid housing, a first endportion comprising a rigid tubular male member configured to beengageable with a female connector and positioned at a first end of thehousing, a second end portion comprising a rigid tubular female memberand positioned at a second end of the housing; the female member beingconfigured to define at least a first arrangement wherein the femalemember is configured to allow a male connector to rotate substantiallyunimpeded in either a first direction or a second direction relative tothe female member, the first direction being defined as the directionthat permits the male connector to threadably engage the female member,and the second direction being defined as the direction that permits themale connector to threadably disengage the female member, and a secondarrangement wherein the female member is configured to prevent or impedethe male connector from rotating in the first direction or the seconddirection relative to the female member; and the female member beingfurther configured to change from the first arrangement to the secondarrangement when the male connector is further rotated in the firstdirection beyond a point at which the male connector is substantiallyfully engaged with the female member; wherein: the female membercomprises an inner member supported by the housing so as to besubstantially prevented from rotating relative to the housing in eitherthe first or second arrangement and an outer member configured so as tobe threadably engageable by the male connector; in the firstarrangement, the outer member is substantially prevented from rotatingrelative to the inner member and, in the second arrangement, the outermember is substantially permitted to rotate in either the firstdirection or the second direction relative to the inner member; and theinner member comprises at least one protrusion and the outer membercomprises at least one channel configured to receive the at least oneprotrusion, each protrusion is configured to break off whenapproximately 3 in-lb to approximately 5 in-lb or more of torque isapplied to the male connector relative to the luer connector.
 32. Theluer connector of claim 31, wherein each protrusion is configured tobreak off when the male connector is rotated in the first directionbeyond the point where the male connector is substantially fully engagedwith the female member.
 33. The luer connector of claim 31, wherein theluer connector comprises at least one material selected from the groupconsisting of rigid plastic, polycarbonate, glass-filled plastic, metal,and metal alloy.
 34. The luer connector of claim 31, further comprisinga male luer tip with a tapering interior surface at the first end. 35.The luer connector of claim 31, further comprising a valve memberconfigured to alter the flow of a fluid through the luer connector. 36.The luer connector of claim 35, wherein the valve member is rigid. 37.The luer connector of claim 35, wherein the valve member at leastpartially extends through the housing and comprises: a first opened endand a second closed end; a passageway within the valve member; anoutwardly extending flange near the second end adapted to seal a hollowbore at the second end of the housing when placed in contact with thetapering interior surface of the housing; at least one opening near theclosed end of the valve member extending outwardly from the passagewaythrough the valve member; at least one strut connected to the valvemember and extending towards the second end of the valve member, the atleast one strut extending substantially parallel to the central axis ofthe valve member and at least partially surrounding a narrow section ofthe valve member ending in the second closed end; a retaining memberconfigured to couple the valve member and the housing; and a sealingelement disposed within the housing and configured to inhibit fluidcommunication through the hollow bore of the housing between theinterior of the male luer tip of the housing and the first end of thehousing.
 38. The luer connector of claim 31, comprising a plurality ofchannels uniformly spaced about an inside surface of the outer member.39. A method of using the luer connector of claim 31, comprising:threadably engaging the female member of the luer connector with themale connector; and rotating the male connector relative to the femalemember in the first direction beyond the point at which the at least oneprotrusion breaks off of the outer member.
 40. The method of using theluer connector of claim 39, further comprising confirming that the luerconnector is in the second arrangement by rotating the male connector inthe first direction relative to the female member after rotating themale connector relative to the female member in the first directionbeyond the point at which the at least one protrusion breaks off of theouter member.
 41. The luer connector of claim 31, wherein eachprotrusion is configured to break off when approximately 4 in-lb or moreof torque is applied to the male connector relative to the luerconnector.
 42. A luer connector comprising: a rigid housing, a first endportion thereof comprising a rigid male member configured to beengageable with a female connector and positioned at a first end of thehousing, a second end portion thereof comprising a rigid female memberand positioned at a second end of the housing; and a locking elementdetachably supported by the luer connector; wherein: the luer connectoris configured to define at least a first arrangement wherein the lockingelement holds the female member in a substantially fixed rotationalposition relative to the housing and a second arrangement wherein thefemale member is configured to substantially freely rotate relative tothe housing; the luer connector is configured to change from the firstarrangement wherein the locking element is supported by the luerconnector to the second arrangement wherein the locking element isirreversibly detached from the luer connector when a threshold force isapplied to the luer connector sufficient to cause the locking element tobreak away from the luer connector.
 43. The luer connector of claim 42,wherein the locking element comprises a protrusion.
 44. The luerconnector of claim 42, wherein the locking element comprises a channel.45. The luer connector of claim 42, wherein the luer connector comprisesa first member supported by the housing and a second member incommunication with the first member, the second member being threadablyengageable by a male connector.
 46. The luer connector of claim 45,wherein at least one locking element is supported by either the firstmember or the second member.
 47. The luer connector of claim 42, whereinthe locking element is configured to detach from the luer connector whenapproximately 3 in-lb to approximately 5 in-lb or more of torque isexerted on the female member relative to the luer connector.
 48. Theluer connector of claim 42, wherein the locking element is configured todetach from the luer connector when approximately 4 in-lb or more oftorque is exerted on the female member relative to the luer connector.49. The luer connector of claim 42, wherein the locking element isconfigured to detach from the luer connector when approximately 5 in-lbor more of torque is exerted on the female member relative to the luerconnector.
 50. The luer connector of claim 42, wherein the luerconnector comprises at least one material selected from the groupconsisting of rigid plastic, polycarbonate, glass-filled plastic, metal,and metal alloy.
 51. The luer connector of claim 42, further comprisinga male luer tip with a tapering interior surface at the first end. 52.The luer connector of claim 42, further comprising a valve memberconfigured to alter the flow of a fluid through the luer connector. 53.The luer connector of claim 52, wherein the valve member is rigid. 54.The luer connector of claim 52, wherein the valve member at leastpartially extends through the housing and comprises: a first opened endand a second closed end; a passageway within the valve member; anoutwardly extending flange near the second end adapted to seal a hollowbore at the second end of the housing when placed in contact with thetapering interior surface of the housing; at least one opening near theclosed end of the valve member extending outwardly from the passagewaythrough the valve member; at least one strut connected to the valvemember and extending towards the second end of the valve member, the atleast one strut extending substantially parallel to the central axis ofthe valve member and at least partially surrounding a narrow section ofthe valve member ending in the second closed end; a retaining memberconfigured to couple the valve member and the housing; and a sealingelement disposed within the housing and configured to inhibit fluidcommunication through the hollow bore of the housing between theinterior of the male luer tip of the housing and the first end of thehousing.
 55. A method of using the luer connector of claim 42,comprising: threadably engaging the female member of the luer connectorwith the male connector; and rotating the male connector relative to thefemale member of the luer connector so as to threadedly engage the maleconnector and the female member; and detaching the linking element fromthe luer connector by exerting a threshold force on the locking element.56. The method of using the luer connector of claim 55, furthercomprising opening a valve member supported by the housing to increasethe flow of a fluid through the luer connector.
 57. The method of usingthe luer connector of claim 55, further comprising axially displacing atleast one strut so as to open a valve member supported by the housing toincrease the flow of a fluid through the luer connector.
 58. The methodof using the luer connector of claim 55, further comprising confirmingthat the locking element is detached from the luer connector.